Abiomed Automated Impella Controller recalled for motor control and pump failure risks
Abiomed is recalling 91 Automated Impella Controllers due to hardware defects that could interrupt motor controls or cause pump failure in this cardiac support device.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified FDA Class I, which per the regulatory rubric mandates a minimum Severe rating. No injuries or deaths have been reported, but defects in a life-critical cardiac pump device—including potential motor control interruption and pump failure—represent serious, documented hardware risks.
Plain-English summary
Abiomed, Inc. is recalling 91 units of the Automated Impella Controller (AIC), a cardiac support device used to assist heart function during treatment. This FDA Class I recall addresses hardware defects identified in a retrospective review that could compromise device safety and patient care.
The defects include: electrostatic discharge coupling that could interrupt motor controls; potential memory card dislodgement causing startup and data logging failures; improper fan wire routing potentially causing console boot failures; and capacitor issues that could cause pump failure, purge failure, or fuse failures. These hardware updates have been implemented through Abiomed's service process.
Affected units are distributed across 14 U.S. states and nine countries including Canada, Brazil, Colombia, and the United Kingdom. Healthcare providers with affected units should contact Abiomed to arrange for the required hardware service updates.
The recalled product
- Product
- Automated Impella Controller (AIC); Product Code: 0042-0000-US;
- Manufacturer
- Abiomed, Inc.
- Hazard
- electrostatic-discharge
- motor-control-failure
- startup-failure
- boot-failure
- pump-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 0042-0000-US
- UDI-DI: 00813502010022
- Serial Numbers: IC2449
- IC2451
- IC2452
- IC2453
- IC2459
- IC2460
- IC1096
- IC1142
- IC1202
- IC1203
- IC1224
- IC1231
- IC1238
- IC1284
- IC1285
- IC1390
- IC1545
- IC1577
Distribution
Distributed nationwide across the United States.
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