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Autocat Intra-Aortic Balloon Pump Series

by Arrow Intl., Inc.

510(k) K060309

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

20 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060309 Date6 Apr 2006ClearedStatusActive

Recalls

29 recalls · 20 ongoing · FDA

  • 20 recalls, same reason

    • Ongoing Z-0451-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0448-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0452-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0456-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0430-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0444-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0432-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0454-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0426-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0450-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0427-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0446-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0429-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0445-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0447-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0431-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0453-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0428-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0449-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0455-2023 FDA Class I initiated 17 Oct 2022

    There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

  • 8 recalls, same reason

    • Terminated Z-2410-2020 FDA Class I initiated 20 May 2020
    • Terminated Z-2409-2020 FDA Class I initiated 20 May 2020
    • Terminated Z-2412-2020 FDA Class I initiated 20 May 2020
    • Terminated Z-2415-2020 FDA Class I initiated 20 May 2020
    • Terminated Z-2414-2020 FDA Class I initiated 20 May 2020
    • Terminated Z-2413-2020 FDA Class I initiated 20 May 2020
    • Terminated Z-2408-2020 FDA Class I initiated 20 May 2020
    • Terminated Z-2411-2020 FDA Class I initiated 20 May 2020

    A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

    • Terminated Z-0550-2008 FDA Unclassified (pre-2012) initiated 12 Nov 2007

    Leak may occur in the helium drive system for the IABP

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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