Impella Heart Assist Controller Units Recalled for Potential Pump Stop
Abiomed is recalling 71 Impella heart assist pump controllers with a defective pump driver circuit assembly that may cause decreased pump performance or pump stop, triggering failure alarms.
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 is an FDA Class I recall, which carries a minimum severity of 4. The potential for pump failure in an implantable cardiac assist device represents a serious patient safety risk, though no deaths or serious injuries have been reported in the source material.
Plain-English summary
Abiomed, Inc. is recalling specific Automated Impella Controllers (AIC) with Pump Driver Circuit Assembly defects. These devices assist heart function in patients with severe cardiac conditions. Seventy-one units are affected. The defective circuit assembly does not meet current specifications and may lead to decreased pump performance or complete pump stop, triggering "Impella Failure" or "Impella Stopped Controller Failure" alarms.
The affected controllers were distributed to 16 U.S. states and internationally. U.S. locations include Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, and Texas. International distribution was to Canada, Germany, Great Britain, Italy, Netherlands, and Norway. The FDA has issued specific serial numbers for each product code to identify affected units.
The recalled product
- Product
- Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Package
- Manufacturer
- Abiomed, Inc.
- Hazard
- device-malfunction
- pump-failure
- circuit-defect
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)
- 1. Product Code: 0042-0000-US
- GTIN: 813502010022
- Serial Numbers: IC1026
- IC1029
- IC1043
- IC1046
- IC1040
- IC1047
- IC1088
- IC1089
- IC1093
- IC1110
- IC1167
- IC1221
- IC1225
- IC1222
- IC1258
- IC1250
- IC1272
- IC1293
Distribution
Distributed in 17 states:
- AR
- AZ
- CA
- CO
- CT
- FL
- GA
- ID
- MA
- MI
- MO
- MS
- NJ
- NY
- OH
- PA
- TX
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