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Impella 0042-0010-UK

by Abiomed, Inc. United States GUDID

Product code OZD

Regulatory status

as of 24 Oct 2026

Recall ongoing. 23 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813502010978 UDI-DIDate11 Sep 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

27 recalls · 23 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3149-2026 FDA Class I initiated 12 Aug 2026
    • Ongoing Z-3150-2026 FDA Class I initiated 12 Aug 2026
    • Ongoing Z-3148-2026 FDA Class I initiated 12 Aug 2026

    The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

    • Ongoing Z-2457-2026 FDA Class I initiated 18 May 2026

    Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

    • Ongoing Z-2360-2026 FDA Class I initiated 14 May 2026

    Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

    • Ongoing Z-2211-2026 FDA Class I initiated 20 Apr 2026

    A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.

    • Ongoing Z-1589-2026 FDA Class I initiated 18 Feb 2026

    Increased risk of purge leaks with Generation 1 purge cassettes.

    • Ongoing Z-1591-2026 FDA Class I initiated 16 Feb 2026

    Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

  • 3 recalls, same reason

    • Ongoing Z-1469-2026 FDA Class I initiated 27 Jan 2026
    • Ongoing Z-1470-2026 FDA Class I initiated 27 Jan 2026
    • Ongoing Z-1471-2026 FDA Class I initiated 27 Jan 2026

    Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

    • Ongoing Z-1030-2026 FDA Class II initiated 4 Dec 2025

    Device packaged in incorrect outer box carton.

    • Ongoing Z-0069-2026 FDA Class I initiated 1 Oct 2025

    Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

    • Ongoing Z-0136-2026 FDA Class I initiated 16 Sep 2025

    Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

    • Ongoing Z-2164-2025 FDA Class I initiated 23 Jun 2025

    A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

  • 2 recalls, same reason

    • Ongoing Z-0829-2025 FDA Class I initiated 12 Dec 2024
    • Ongoing Z-0830-2025 FDA Class I initiated 12 Dec 2024

    Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

    • Ongoing Z-2319-2024 FDA Class I initiated 31 May 2024

    Nine (9) Impella CP pumps failed inspection and were inadvertently released.

    • Ongoing Z-0980-2024 FDA Class I initiated 27 Dec 2023

    IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

    • Ongoing Z-0636-2024 FDA Class II initiated 6 Dec 2023

    The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature

    • Ongoing Z-1590-2023 FDA Class I initiated 17 Apr 2023

    The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.

    • Ongoing Z-3251-2026 FDA Class II initiated 19 Feb 2019

    Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.

    • Ongoing Z-2238-2026 FDA Class I initiated 17 Jan 2011

    Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.

  • 2 recalls, same reason

    • Terminated Z-0440-2024 FDA Class II initiated 10 Oct 2023
    • Terminated Z-0441-2024 FDA Class II initiated 10 Oct 2023

    Pump not detected as connected to controller due to software issue.

    • Terminated Z-1175-2024 FDA Class II initiated 1 Mar 2021

    Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.

    • Terminated Z-0345-2020 FDA Class II initiated 4 Sep 2019

    This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.

Specification

GUDID · synced 22 Oct 2026

Trade Name
Impella
Generic Name
Intracardiac circulatory assist axial-pump catheter control unit
Model / Ref / Catalog
0042-0010-UK
Primary DI / UDI-DI
00813502010978
PMA Number
FDA Product Code
OZD, PYX
GMDN Term
Intracardiac circulatory assist axial-pump catheter control unit
Device Class
Class III
Regulation Number
870.4360
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

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Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (10)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No

Sources (1)

  • FDA UDI 35e4e2a9-84f0-4064-a1bf-07d4bbb022ab 36 fields · synced 22 Oct 2026