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Impella 1000441

by Abiomed, Inc.

Impella 1000441 is a Class II device made by Abiomed, Inc., cleared under FDA 510(k) K201116 on 15 Jun 2020 and listed in FDA GUDID since 30 Jun 2023 (UDI-DI 00813502012910), active as of 9 Nov 2026. 13 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

13 ongoing

This device is named in the recall

Documents

510(k) K201116

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813502012910 UDI-DI Date30 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201116 Date15 Jun 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201116 decided 15 Jun 2020 Active
  • FDA GUDID UDI-DI 00813502012910 listed 30 Jun 2023 Listed

Recalls

13 recalls · 13 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-2687-2026 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-2690-2026 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.

Timeline

15 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-2690-2026

5 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
1000441
Primary DI / UDI-DI
00813502012910
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 (K201116)

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
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)