Impella RP Flex cardiac pump recalled for thrombus formation risk
The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.
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: FDA Class I designation requires a minimum severity of 4. No deaths or hospitalizations have been reported in the source text, so the score remains at 4 rather than escalating to Critical.
Plain-English summary
The Impella RP Flex with SmartAssist (Product Number 1000323) is an intracardiac microaxial blood pump manufactured by Abiomed, Inc., used to provide mechanical cardiac support in clinical settings.
The FDA has issued a Class I recall due to a higher-than-expected rate of thrombus (blood clot) formation or deposition in the device. The hazard is that blood clots forming on indwelling central venous lines or cannulas may break free and enter the pump, potentially causing reduced blood flow, loss of cardiac support, or hemolysis (destruction of red blood cells).
Approximately 166 units have been distributed nationwide, including in Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, South Carolina, Texas, and Wisconsin.
Patients implanted with this device should contact their healthcare provider immediately. Healthcare providers should review affected patients and consider appropriate clinical management in consultation with Abiomed and the FDA.
The recalled product
- Product
- Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiac Support
- Affected units
- 166
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 (1)
- UDI-DI: 00813502012811
Distribution
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