510(k) · Cleared

Recalled · Class I · 2025

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

K163542510(k) SpecialCleared Jan 31, 201746-day reviewClass II21 CFR 870.3535Recalls 14 (7 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Datascope Corp. · DSP System, Balloon, Intra-Aortic And Control

Cleared on Jan 31, 2017 as substantially equivalent to K151254 (Datascope Corp., 2015) after a 46-day review. Its family tree reaches back 11 generations to 1990. 11 of the 66 devices in its family, counting itself, have a Class I recall. It has been recalled 14 times, including 7 Class I recalls.

Decided: Jan 31, 2017
Review: 46 days
Class: Class II
Product code: DSP
Recalls: 14 (7 Class I)
Predicates: 1

Its longest line of descent runs back 11 generations to K892222 (1990). 65 ancestors in all, the oldest K790775 (1979). No later device cites it as a predicate yet. 11 of the 66 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 11 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
7 generations between
3 generations backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
2 generations backK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
1 generation backK151254 CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Recalled (Class I)
This deviceK163542 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE…Datascope Corp. · 2017

Show all 11 generations

Root · 11 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
10 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
9 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
8 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
7 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
6 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
5 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
4 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
3 generations backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
2 generations backK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
1 generation backK151254 CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Recalled (Class I)
This deviceK163542 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE…Datascope Corp. · 2017

Class I recalls in this family

K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pumpdirect predicate · 2015
K112372 Cardiosave Hybrid Intra-Aortic Balloon Pump2 generations back · 2011
K063525 Datascope Fiber Optic Pressure Sensor…3 generations back · 2007
K060309 Autocat Intra-Aortic Balloon Pump Series4 generations back · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K892222	9.5F Percu Double Lumen Intra-Aortic Balloon	Kontron Instruments, Inc.	1990	—
−10	K963187	Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930…	Boston Scientific Corp	1996	—
−9	K972113	30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel	Boston Scientific Corp	1997	—
−8	K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…	Datascope Corp.	1998	—
−7	K994157	Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…	Datascope Corp.	2000	—
−6	K013326	Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…	Datascope Corp.	2001	—
−5	K031569	Datascope CA 40 8FR. Iabs, Model 0684-00-04XX	Datascope Corp.	2003	—
−4	K041281	Datascope 7.5FR. Iab Catheter and Accessories	Datascope Corp.	2004	7
−3	K063525	Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…	Datascope Corp.	2007	Class I
−2	K112372	Cardiosave Hybrid Intra-Aortic Balloon Pump	Cardiac Assist, Maquet Cardiovascular, LLC	2011	Class I
−1	K151254	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump	Datascope Corp.	2015	Class I
0 (this device)	K163542	CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion…	Datascope Corp.	2017	—

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

FIG. 1 — Lineage of K163542, 1990–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

11 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K151254	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Summary page 4 …21 CFR 870.3535 Regulatory Class: Class II Product Code: DSP PREDICATE DEVICE INFORMATION: CARDIOSAVE Intra-Aortic Balloon Pump (K151254). DEVICE DESCRIPTION: The CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is a cardiac assist device. It supports the heart's left…	Datascope Corp.	2015	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (11 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 4, 2025	Class II	Z-0917-2026	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.
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.

The 5 latest of 14 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.

K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 112 Class I recalls
K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations back · ◆ 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 4 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 · 4 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 · 4 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 · 4 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 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

Nearest 5 of 10; all are on the web page.

What does this lineage say?

The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
17 of the 65 ancestors have a recall of any class; 10 have a Class I recall.

How does its category compare?

All DSP devices

DSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Intra-Aortic Balloon Pump 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/K163542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163542: CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163542

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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