Impella 0046-0035

• FDA PMA P170011 decided 20 Sep 2017 Active
• FDA GUDID UDI-DI 00813502011869 listed 19 Jun 2023 Listed

• 3 recalls, same reason

  • Ongoing Z-0208-2027 FDA Not yet classified ·initiated 18 Sep 2026 ·on shared PMA P170011
  • Ongoing Z-0210-2027 FDA Not yet classified ·initiated 18 Sep 2026 ·on shared PMA P170011
  • Ongoing Z-0209-2027 FDA Not yet classified ·initiated 18 Sep 2026 ·on shared PMA P170011

  Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console. 3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange. 4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.

• 3 recalls, same reason

  • Ongoing Z-3150-2026 FDA Class I ·initiated 12 Aug 2026 ·on shared PMA P170011
  • Ongoing Z-3148-2026 FDA Class I ·initiated 12 Aug 2026 ·on shared PMA P170011
  • Ongoing Z-3149-2026 FDA Class I ·initiated 12 Aug 2026 ·on shared PMA P170011

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

• • Ongoing Z-2360-2026 FDA Class I ·initiated 14 May 2026 ·on shared PMA P170011

  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 ·on shared PMA P170011

  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 ·on shared PMA P170011

  Increased risk of purge leaks with Generation 1 purge cassettes.

• 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-0069-2026 FDA Class I ·initiated 1 Oct 2025 ·on shared PMA P170011

  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 ·on shared PMA P170011

  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 ·on shared PMA P170011

  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-0980-2024 FDA Class I ·initiated 27 Dec 2023 ·on shared PMA P170011

  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-3251-2026 FDA Class II ·initiated 19 Feb 2019 ·on shared PMA P170011

  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 ·on shared PMA P170011

  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.

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

1. 27 Jan 2026 Recall initiated FDA recalls Z-1471-2026
2. 18 Feb 2026 Recall initiated FDA recalls Z-1589-2026
3. 20 Apr 2026 Recall initiated FDA recalls Z-2211-2026
4. 14 May 2026 Recall initiated FDA recalls Z-2360-2026
5. 12 Aug 2026 Recall initiated FDA recalls Z-3150-2026
6. 12 Aug 2026 Recall initiated FDA recalls Z-3148-2026
7. 12 Aug 2026 Recall initiated FDA recalls Z-3149-2026
8. 18 Sep 2026 Recall initiated FDA recalls Z-0208-2027
9. 18 Sep 2026 Recall initiated FDA recalls Z-0210-2027
10. 18 Sep 2026 Recall initiated FDA recalls Z-0209-2027

13 earlier events are in the sections above.

Trade name

Impella

Generic name

Intracardiac circulatory assist axial-pump catheter

Model / Ref / Catalog

0046-0035

Primary DI / UDI-DI

00813502011869

PMA number

P170011 ↗

FDA product code

PYX

GMDN term

Intracardiac circulatory assist axial-pump catheter

Device class

Class III

Regulation number

870.4360

GUDID distribution status

In Commercial Distribution

Category: Intracardiac circulatory assist axial-pump catheter

• Impella 14Fr Introducer Kit, long 0052-0017

  Class II

  GUDID on market

• Impella RP Flex Introducer Kit 2000342 Open recall

  Class II

  FDA 510(k) K201116 Active Cleared 15 Jun 2020 GUDID on market

• Impella 0042-0000-JP Open recall

  Class III

  FDA PMA ×2 Active Approved 23 Mar 2015 GUDID on market

• Impella 0042-0010-UK Open recall

  Class III

  FDA PMA ×2 Active Approved 23 Mar 2015 GUDID on market

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