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Impella 0052-0001

by Abiomed, Inc.

Impella 0052-0001 is a Class II device made by Abiomed, Inc., cleared under FDA 510(k) K192769 on 18 Nov 2019 and listed in FDA GUDID since 21 Oct 2016 (UDI-DI 00813502011302), active as of 9 Nov 2026. 20 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K192769

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) from GUDID NumberK192769 Date18 Nov 2019IssuedStatusActive
United StatesGUDID listing Number00813502011302 UDI-DI Date21 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192769 decided 18 Nov 2019 Active
  • FDA GUDID UDI-DI 00813502011302 listed 21 Oct 2016 Listed

Recalls

20 recalls · 20 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-2690-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2692-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2688-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2685-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2689-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2691-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2682-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2693-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2681-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2684-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2683-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2686-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2687-2026 FDA Class I initiated 11 Jun 2026

    A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

  • 6 recalls, same reason

    • Ongoing Z-0652-2024 FDA Class II initiated 7 Nov 2023
    • Ongoing Z-0646-2024 FDA Class II initiated 7 Nov 2023
    • Ongoing Z-0651-2024 FDA Class II initiated 7 Nov 2023
    • Ongoing Z-0647-2024 FDA Class II initiated 7 Nov 2023
    • Ongoing Z-0648-2024 FDA Class II initiated 7 Nov 2023
    • Ongoing Z-0650-2024 FDA Class II initiated 7 Nov 2023

    Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

    • Ongoing Z-0649-2024 FDA Class II initiated 7 Nov 2023

    Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.

Timeline

22 dated events

  1. Recall initiated FDA recalls Z-2685-2026
  2. Recall initiated FDA recalls Z-2689-2026
  3. Recall initiated FDA recalls Z-2691-2026
  4. Recall initiated FDA recalls Z-2682-2026
  5. Recall initiated FDA recalls Z-2693-2026
  6. Recall initiated FDA recalls Z-2681-2026
  7. Recall initiated FDA recalls Z-2684-2026
  8. Recall initiated FDA recalls Z-2683-2026
  9. Recall initiated FDA recalls Z-2686-2026
  10. Recall initiated FDA recalls Z-2687-2026

12 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Impella
Generic name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
0052-0001
Primary DI / UDI-DI
00813502011302
510(k) Number
FDA product code
DYB
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class II
Regulation number
870.1340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K192769)

and 3 more cleared under K192769

Similar devices in this category

Other devices filed under Vascular catheter introduction set, nonimplantable.

Other devices from Abiomed, Inc.

See all devices from Abiomed, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)