Recall Z-0208-2027— Abiomed, Inc.

Class I FDA medical device recall by Abiomed, Inc., initiated 2026-09-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.. Reason: 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..

Recalling firm

Abiomed, Inc.

Classification

Class I

Status

Ongoing

Initiated

2026-09-18

Firm location

Danvers, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.