510(k) · Cleared
Recalled · Class I · 2025CARDIOSAVE Intra-Aortic Balloon Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · DSP System, Balloon, Intra-Aortic And Control
Cleared on May 31, 2018 as substantially equivalent to K112372 (Cardiac Assist, Maquet Cardiovascular, LLC, 2011) after a 31-day review. Its family tree reaches back 10 generations to 1990. 10 of the 65 devices in its family, counting itself, have a Class I recall. It has been recalled 36 times, including 27 Class I recalls.
- Decided
- May 31, 2018
- Review
- 31 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 36 (27 Class I)
- Predicates
- 1
Its longest line of descent runs back 10 generations to K892222 (1990). 64 ancestors in all, the oldest K790775 (1979). No later device cites it as a predicate yet. 10 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 6 generations between
- 3 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 2 generations backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- 1 generation backK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
- This deviceK181122 CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018
Show all 10 generations
- Root · 10 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 9 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- 8 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
- 7 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- 6 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
- 5 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
- 4 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- 3 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
- 2 generations backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- 1 generation backK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
- This deviceK181122 CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −9 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| −8 | K972113 | 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel | Boston Scientific Corp | 1997 | — |
| −7 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| −6 | K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models… | Datascope Corp. | 2000 | — |
| −5 | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC… | Datascope Corp. | 2001 | — |
| −4 | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XX | Datascope Corp. | 2003 | — |
| −3 | K041281 | Datascope 7.5FR. Iab Catheter and Accessories | Datascope Corp. | 2004 | 7 |
| −2 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| −1 | K112372 | Cardiosave Hybrid Intra-Aortic Balloon Pump | Cardiac Assist, Maquet Cardiovascular, LLC | 2011 | Class I |
| 0 (this device) | K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | 2018 | — |
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 |
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.
10 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 |
|---|---|---|---|
| * | K112372 | Cardiosave Hybrid Intra-Aortic Balloon PumpSummary page 4…ber: 21 CFR 870.3535 Regulatory Class: Class II Product Code: DSP Predicate Device CARDIOSAVE Intra-Aortic Balloon Pump (K112372) Information: Device The CARDIOSAVE IABP (Hybrid Model) is a cardiac assist Description: device. It suppo… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Aug 8, 2024 | Class I | Z-3136-2024 | Software design | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue… |
| Aug 8, 2024 | Class I | Z-3134-2024 | Software design | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue… |
| Aug 8, 2024 | Class I | Z-3135-2024 | Software design | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue… |
| Aug 8, 2024 | Class I | Z-3137-2024 | Software design | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue… |
| Jul 31, 2023 | Class I | Z-2431-2023 | Under Investigation by firm | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into… |
| Jul 31, 2023 | Class II | Z-2487-2023 | Under Investigation by firm | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. |
| Jul 31, 2023 | Class I | Z-2436-2023 | Under Investigation by firm | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was… |
| Jul 31, 2023 | Class I | Z-2438-2023 | Under Investigation by firm | Users were identifying autofill failure conditions on the devices causing pump stops. |
| Jul 31, 2023 | Class I | Z-2435-2023 | Under Investigation by firm | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was… |
| Jul 31, 2023 | Class I | Z-2437-2023 | Under Investigation by firm | Users were identifying autofill failure conditions on the devices causing pump stops. |
| Jul 31, 2023 | Class II | Z-2486-2023 | Under Investigation by firm | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. |
| Jul 31, 2023 | Class I | Z-2432-2023 | Under Investigation by firm | Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into… |
| Jul 31, 2023 | Class I | Z-2434-2023 | Device Design | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. |
| Jul 31, 2023 | Class I | Z-2433-2023 | Device Design | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. |
| Jun 5, 2023 | Class I | Z-2149-2023 | Device Design | IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to… |
| Jun 5, 2023 | Class I | Z-2150-2023 | Device Design | IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to… |
| Jun 5, 2023 | Class I | Z-2151-2023 | Component design/selection | An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy. |
| Jun 5, 2023 | Class I | Z-2152-2023 | Component design/selection | An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy. |
| Feb 7, 2023 | Class I | Z-1148-2023 | Software design | An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the… |
| Feb 7, 2023 | Class I | Z-1147-2023 | Software design | An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the… |
| Feb 7, 2023 | Class II | Z-1231-2023 | Equipment maintenance | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted. |
| Feb 7, 2023 | Class II | Z-1232-2023 | Equipment maintenance | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted. |
| Dec 19, 2022 | Class I | Z-0885-2023 | Device Design | The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter. |
| Dec 19, 2022 | Class I | Z-0886-2023 | Device Design | The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter. |
| 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-0076-2022 | 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-2616-2021 | 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… |
| 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. |
| Sep 20, 2018 | Class I | Z-0099-2019 | Device Design | There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft. |
| Sep 20, 2018 | Class I | Z-0100-2019 | Device Design | There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft. |
The 5 latest of 36 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.
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Direct predicate · ◆ on the line of descent in FIG. 110 Class I recalls
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 3 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 · 3 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 · 3 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 · 3 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 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
- K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 16 of the 64 ancestors have a recall of any class; 9 have a Class I recall.
- 1 other device also cites its predicate K112372.
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. 2018, 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 IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181122: CARDIOSAVE Intra-Aortic Balloon Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181122
Report an extraction error
Are you the manufacturer?
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