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Abiomed Impella14Fr Introducer Kit, 13cm & 25cm 0052-3046

by Abiomed, Inc.

Ref 0052-3046

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

20 ongoing

Recall on shared 510(k) K192769; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813502011678 Basic UDI-DI 00813502011678UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813502011678 UDI-DI Date25 Feb 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

20 recalls · 20 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-2690-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2692-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2688-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2685-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2689-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2691-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2682-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2693-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2681-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2684-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2683-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2686-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769
    • Ongoing Z-2687-2026 FDA Class I initiated 11 Jun 2026 on shared 510(k) K192769

    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 on shared 510(k) K192769
    • Ongoing Z-0646-2024 FDA Class II initiated 7 Nov 2023 on shared 510(k) K192769
    • Ongoing Z-0651-2024 FDA Class II initiated 7 Nov 2023 on shared 510(k) K192769
    • Ongoing Z-0647-2024 FDA Class II initiated 7 Nov 2023 on shared 510(k) K192769
    • Ongoing Z-0648-2024 FDA Class II initiated 7 Nov 2023 on shared 510(k) K192769
    • Ongoing Z-0650-2024 FDA Class II initiated 7 Nov 2023 on shared 510(k) K192769

    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 on shared 510(k) K192769

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Abiomed Impella14Fr Introducer Kit, 13cm & 25cm
Generic Name
Vascular catheter introduction set, nonimplantable
Device Name
Impella CP Introducer Kit
Model / Reference
0052-3046
Primary DI / UDI-DI
00813502011678
Basic UDI-DI
B-00813502011678
510(k) Number
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class IIa
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K192769)

Other devices from Abiomed, Inc.

See all devices from Abiomed, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No