Abiomed, Inc. is recalling 33,107 Generation 1 purge cassettes, which are used both individually and as part of various Impella Pump Sets. These critical components are being recalled because of an increased risk of leaks in the purge system, which can interfere with the essential cardiac support the pump provides to patients. Consumers and medical facilities are advised to contact their healthcare provider or Abiomed directly for guidance on handling affected devices.
A leak in the purge cassette can cause the Impella heart pump to fail or operate incorrectly. If the pump stops providing mechanical support to a patient’s heart, it can lead to life-threatening complications or death.
Manufacturer guidance and potential correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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