510(k) · Cleared

Recalled · Class I · 2016

Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters

K981660510(k) TraditionalCleared Oct 16, 1998158-day reviewClass II21 CFR 870.3535Recalls 2 (2 Class I)

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

C.R. Bard, Inc. · DSP System, Balloon, Intra-Aortic And Control

Cleared on Oct 16, 1998 after a 158-day review. The FDA summary names its predicate without a number. 11 of the 20 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.

Decided: Oct 16, 1998
Review: 158 days
Class: Class II
Product code: DSP
Recalls: 2 (2 Class I)
Predicates: 0

19 later devices descend from it, 2 citing it directly. 11 of the 20 devices in this family, counting this one, have a Class I recall.

This deviceK981660 Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersC.R. Bard, Inc. · 1998
Descendant · cites it directly · 18 of its ownK021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor…Arrow Intl., Inc. · 2002 · Recalled (Class I)
Descendant · 2 generations on · 14 of its ownK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Recalled (Class I)
Descendant · 2 generations on · 9 of its ownK040801 Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · Recalled
Descendant · cites it directly · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
Descendant · 3 generations on · 4 of its ownK162820 AC3 Series IABP SystemArrow International, Inc. · 2017 · Recalled (Class I)

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2002high 3 (2017) · low 0 (2003)2026

Class I recalls in this family

K021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a…cites it directly · 2002
K063525 Datascope Fiber Optic Pressure Sensor…cites it directly · 2007
K200634 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2 generations on · 2020
K060309 Autocat Intra-Aortic Balloon Pump Series2 generations on · 2006

Most influential descendants

Showing 5 of 19 · See all

K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…Arrow Intl., Inc. · 2002 · cites it directly18descendants
K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations on14descendants
K040801Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · 2 generations on9descendants
K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · cites it directly8descendants
K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K981660	Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters	C.R. Bard, Inc.	1998	—
+1	K021462	Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a…	Arrow Intl., Inc.	2002	Class I
+2	K060309	Autocat Intra-Aortic Balloon Pump Series	Arrow Intl., Inc.	2006	Class I
+2	K040801	Intra-Aortic Balloon (Iab)	Arrow Intl., Inc.	2004	13
+1	K063525	Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…	Datascope Corp.	2007	Class I
+3	K162820	AC3 Series IABP System	Arrow International, Inc.	2017	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	1
2004	1	0
2006	1	1
2007	1	1
2011	2	1
2012	1	0
2013	1	0
2015	1	1
2017	3	2
2018	1	1
2019	2	0
2020	2	2
2023	1	0
2025	1	0

FIG. 1 — Lineage of K981660, 1998–2025Source: 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? (2)

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
*	—	9Fr. 30cc ArmorGlide coated TaperSeal and RediGuard IAB catheters Named without a submission number			—
*	—	DataScope IAB catheters for sheathless insertion Named without a submission number			—

What descends from it? (19)

See all 19

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021462	Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement… Class I	Arrow Intl., Inc.	2002	18
K063525	Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… Class I	Datascope Corp.	2007	8

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 10, 2016	Class I	Z-1061-2016	Process control	The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Feb 10, 2016	Class I	Z-1063-2016	Process control	The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

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.

K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 128 Class I recalls
K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 111 Class I recalls
K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 3 generations on · ◆ 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls

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

What does this lineage say?

Of its descendants, K021462 (Arrow Intl., Inc., 2002) has gone furthest, with 18 descendants of its own.

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.

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?

Refractory left ventricular failure,

Cardiogenic or septic shock,

Unstable refractory angina,

Impending infarction,

Ischemia related ventricular arrhythmias,

Weaning from cardiopulmonary bypass,

Support and stabilization during coronary angioplasty,

Intraoperative pulsatile flow generation,

Associated mechanical complications of acute myocardial infarction,

Support and stabilization of high-risk patients undergoing general surgical procedures.

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/K981660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981660: Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981660

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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