510(k) · Cleared
Recalled · Class I · 2026Cardiosave Hybrid Intra-Aortic Balloon Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Assist, Maquet Cardiovascular, LLC · DSP System, Balloon, Intra-Aortic And Control
Cleared on Sep 15, 2011 as substantially equivalent to K063525 (Datascope Corp., 2007) after a 29-day review. Its family tree reaches back 9 generations to 1990. 12 of the 67 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 31 times, including 10 Class I recalls.
- Decided
- Sep 15, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 31 (10 Class I)
- Predicates
- 1
Its longest line of descent runs back 9 generations to K892222 (1990). 63 ancestors in all, the oldest K790775 (1979). 3 later devices descend from it, 2 citing it directly. 12 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 5 generations between
- 3 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- 2 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 1 generation backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- This deviceK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011
- Descendant · cites it directly · 1 of its ownK151254 CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK181122 CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK163542 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE…Datascope Corp. · 2017 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 8 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- 7 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
- 6 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- 5 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
- 4 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
- 3 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- 2 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 1 generation backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- This deviceK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · cites it directly1descendant
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · cites it directly0descendants
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −8 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| −7 | K972113 | 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel | Boston Scientific Corp | 1997 | — |
| −6 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| −5 | K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models… | Datascope Corp. | 2000 | — |
| −4 | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC… | Datascope Corp. | 2001 | — |
| −3 | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XX | Datascope Corp. | 2003 | — |
| −2 | K041281 | Datascope 7.5FR. Iab Catheter and Accessories | Datascope Corp. | 2004 | 7 |
| −1 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| 0 (this device) | K112372 | Cardiosave Hybrid Intra-Aortic Balloon Pump | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | — |
| +1 | K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | 2015 | Class I |
| +1 | K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | 2018 | Class I |
| +2 | K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion… | Datascope Corp. | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 1 |
| 1998 | 4 | 1 |
| 2000 | 5 | 2 |
| 2001 | 1 | 0 |
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
| 2004 | 1 | 0 |
| 2006 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
12 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSP device
- #1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Summary page 1…REDICATE DEVCE INFORMATION: The CARDIOSAVE TM lntra-Aortic Balloon Pump is substantially equivalent in function and intended use to the CS300 lntra-Aortic Balloon Pump (K063525). DEVICE DESCRIPTION AND INTENDED USE: The CARDIOSAVETM Intra-Aortic Balloon Pump (lABP) is a cardiac assist device. It support… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2026 | Class III | Z-1587-2026 | Under Investigation by firm | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery… |
| Nov 4, 2025 | Class II | Z-0916-2026 | Component design/selection | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. |
| Oct 23, 2025 | Class III | Z-0932-2026 | Process change control | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. |
| Oct 23, 2025 | Class III | Z-0931-2026 | Process change control | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. |
| May 4, 2023 | Class III | Z-1907-2023 | Under Investigation by firm | The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. |
| Apr 4, 2023 | Class II | Z-1462-2023 | Component design/selection | The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle. |
| Feb 28, 2023 | Class II | Z-1278-2023 | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB… |
| Feb 28, 2023 | Class II | Z-1279-2023 | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB… |
| Feb 28, 2023 | Class II | Z-1277-2023 | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB… |
| Feb 28, 2023 | Class II | Z-1276-2023 | Under Investigation by firm | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB… |
| Feb 7, 2023 | Class II | Z-1230-2023 | Under Investigation by firm | There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be… |
| Feb 7, 2023 | Class I | Z-1146-2023 | Under Investigation by firm | An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit. |
| Feb 7, 2023 | Class II | Z-1229-2023 | Under Investigation by firm | There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be… |
| Feb 7, 2023 | Class I | Z-1145-2023 | Under Investigation by firm | An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit. |
| Nov 15, 2021 | Class I | Z-0336-2022 | Device Design | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. |
| Nov 15, 2021 | Class I | Z-0337-2022 | Device Design | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. |
| Sep 21, 2021 | Class I | Z-0091-2022 | Nonconforming Material/Component | A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers. |
| Sep 8, 2021 | Class II | Z-0075-2022 | Device Design | The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. |
| Sep 8, 2021 | Class II | Z-2615-2021 | Software design | The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific… |
| Mar 22, 2021 | Class III | Z-1506-2021 | Software design | There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS). |
| Mar 22, 2021 | Class III | Z-1507-2021 | Software design | There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS). |
| Jun 17, 2019 | Class I | Z-1940-2019 | Use error | If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided. |
| Jun 17, 2019 | Class I | Z-1939-2019 | Use error | Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent… |
| Jun 17, 2019 | Class I | Z-1942-2019 | Use error | If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided. |
| Jun 17, 2019 | Class I | Z-1941-2019 | Use error | If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered. |
| May 3, 2018 | Class I | Z-1928-2018 | Device Design | Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy. |
| Dec 23, 2016 | Class II | Z-1386-2017 | Device Design | Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped. |
| Dec 16, 2015 | Class II | Z-1248-2016 | Other | Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. |
| Jan 30, 2015 | Class II | Z-1140-2015 | Under Investigation by firm | Power supply malfunction complaints related to suboptimal thermal management. |
| Dec 16, 2014 | Class II | Z-1062-2015 | Device Design | Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become… |
| Mar 27, 2012 | Class II | Z-0662-2013 | Device Design | In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result… |
The 5 latest of 31 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 128 Class I recalls
- K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 15 Class I recalls
- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersC.R. Bard, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
- K000729Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 15 of the 63 ancestors have a recall of any class; 8 have a Class I recall.
- Of its descendants, K151254 (Datascope Corp., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K063525.
How does its category compare?
All DSP devicesDSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DSP
1in 2025
2007high 3 (2017) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DSP
140in 2019
2007high 140 (2019) · low 73 (2017)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSP
4in 2025
2007high 33 (2022) · low 0 (2008)2026
Class I (47 since 2007) Class II/III not classified
Adverse event reports per year · DSP
7,422in 2025
2007high 7,422 (2025) · low 404 (2015)2025
MAUDE reports naming product code DSP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 461 |
| 2008 | 0 | — | 0 | 617 |
| 2009 | 2 | — | 14 | 656 |
| 2010 | 0 | — | 8 | 1,019 |
| 2011 | 2 | — | 0 | 590 |
| 2012 | 2 | — | 3 | 490 |
| 2013 | 1 | — | 0 | 495 |
| 2014 | 0 | — | 1 | 1,738 |
| 2015 | 1 | — | 0 | 404 |
| 2016 | 0 | — | 9 (9) | 419 |
| 2017 | 3 | 73 | 0 | 2,164 |
| 2018 | 1 | — | 2 (2) | 3,331 |
| 2019 | 3 | 140 | 3 | 3,552 |
| 2020 | 2 | — | 0 | 3,393 |
| 2021 | 0 | — | 5 (3) | 4,345 |
| 2022 | 0 | — | 33 (33) | 5,113 |
| 2023 | 1 | — | 0 | 6,980 |
| 2024 | 0 | — | 1 | 7,317 |
| 2025 | 1 | — | 4 | 7,422 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CARDIOSAVE TM Intra Aortic Balloon Pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the EG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The target population is adult. The balloon pump is intended for use in the health care facility setting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112372 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112372
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026