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Impella 0052-0038

by Abiomed, Inc.

Ref 0052-0038

Impella 0052-0038 is a device classified as Class IIa in the EU and Class II in the US made by Abiomed, Inc., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-00813502011708), cleared under FDA 510(k) K192769 on 18 Nov 2019 and listed in FDA GUDID since 15 Apr 2020 (UDI-DI 00813502011708), active as of 9 Nov 2026. 20 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

20 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192769

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813502011708 Basic UDI-DI 00813502011708UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813502011708 UDI-DI Date15 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK192769 Date18 Nov 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00813502011708 registered 12 Oct 2026 Active
  • FDA 510(k) K192769 decided 18 Nov 2019 Active
  • FDA GUDID UDI-DI 00813502011708 listed 15 Apr 2020 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

23 dated events

  1. Recall initiated FDA recalls Z-2689-2026
  2. Recall initiated FDA recalls Z-2691-2026
  3. Recall initiated FDA recalls Z-2682-2026
  4. Recall initiated FDA recalls Z-2693-2026
  5. Recall initiated FDA recalls Z-2681-2026
  6. Recall initiated FDA recalls Z-2684-2026
  7. Recall initiated FDA recalls Z-2683-2026
  8. Recall initiated FDA recalls Z-2686-2026
  9. Recall initiated FDA recalls Z-2687-2026
  10. Registered EUDAMED B-00813502011708

13 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Impella
Generic name
Vascular catheter introduction set, nonimplantable
Device name
Impella CP Introducer Kit
Model / Ref / Catalog
0052-0038
Primary DI / UDI-DI
00813502011708
Basic UDI-DI
B-00813502011708
510(k) Number
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1340
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Contains latexEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 00813502011708: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from Abiomed, Inc.

See all devices from Abiomed, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains latex NoEUDAMEDYesGUDID
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)