Abiomed Impella CP with SmartAssist heart pump units recalled for failed inspection
Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the agency's highest classification for medical devices. Class I recalls involve non-compliant devices that pose a serious risk to patient safety.
Plain-English summary
Abiomed, Inc. is recalling 9 Impella CP with SmartAssist left heart support blood pump units (Product No. 1000080, REF 0048-0003). These units failed quality inspection but were inadvertently released for distribution.
The specific inspection failures are not detailed in this recall notice. These devices are used to provide left heart support.
The recalled units are from Lot 1798046 and were distributed domestically in Florida, Massachusetts, Ohio, and Texas.
The recalled product
- Product
- Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
- Manufacturer
- Abiomed, Inc.
- Hazard
- device-malfunction
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 (12)
- Product No.: 1000080 (REF 0048-0003)
- UDI/DI: 00813502012279
- Lot/Serial No.: Lot 1798046
- Serial numbers: 504354
- 504355
- 504356
- 504357
- 504359
- 504360
- 504361
- 504362
- 504363.
Distribution
Distributed in 4 states:
- FL
- MA
- OH
- TX
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