Official recall record

Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.

US FDA — Medical Devices · 2026-09-18 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2026-09-18
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 00813502010022
Brand on record: Abiomed, Inc.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-11-13.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2021-03-01 · US FDA — Medical Devices
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular
2026-04-20 · US FDA — Medical Devices
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
2026-08-12 · US FDA — Medical Devices
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Contr

Other recalls from this brand

2026-09-18 · US FDA — Medical Devices
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-base
2026-09-18 · US FDA — Medical Devices
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-bas
2026-06-11 · US FDA — Medical Devices
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and

All 38 official recall notices naming Abiomed, Inc. on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.