Automated Impella Controller units recalled for pump performance risk
Abiomed is recalling specific Automated Impella Controllers with defective Pump Driver Circuit Assemblies that may cause decreased pump performance or pump stop. The defect triggers Impella Failure or Impella Stopped Controller Failure alarms.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical cardiac support device. The hazard directly threatens pump functionality in heart assist equipment, which poses serious risk of patient harm even though no illnesses or deaths are reported in the source text.
Plain-English summary
Abiomed, Inc. is recalling specific Automated Impella Controllers (AICs) used with heart assist pumps. The affected units contain a Pump Driver Circuit Assembly that does not meet current specifications.
These defective components may lead to decreased pump performance or complete pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm. The 71 affected units are distributed across the United States and internationally (Canada, Germany, Great Britain, Italy, Netherlands, and Norway).
Patients and healthcare providers using affected serial numbers should immediately contact Abiomed or their healthcare provider regarding their device. A complete list of affected serial numbers by product code is available in FDA documentation.
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…
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiac Support
- Affected units
- 71
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
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