In the agency's Nov 4, 2026 enforcement report · Ongoing
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart…
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
- Lot codes and dates
- Product Code
0042-0000-US0042-0000-UK0042-0000-EU0042-0000-IN0042-0000-CA
- UDI
433 of 433 codes
0081350201002200813502011296008135020112890081350201141800813502011272Serial No. IC1014IC1029IC1038IC1043IC1042IC1061IC1075IC1096IC1122IC1190IC1202IC1203IC1224IC1231IC1238IC1269IC1289IC1446IC1612IC1741IC1771IC1852IC1853IC1708IC1964IC2071IC2069IC2154IC2227IC2314IC2315IC2029IC2321IC2428IC2429IC2521IC2561IC2562IC2575IC2664IC2665IC2691IC2692IC2739IC2782IC2840IC2841IC2848IC2891IC2976IC2977IC3009IC3010IC3154IC3155
- Product Code
- Amount recalled
- 428 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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