Abiomed has issued a Class I recall for 33,107 Purge Cassette units used with Impella pump sets worldwide due to purge leaks in Generation 1 cassettes. The leaks raise the risk of compromised device performance. Patients and healthcare providers should stop using the affected devices immediately and follow Abiomed's recall instructions.
Increased risk of purge leaks with Generation 1 purge cassettes.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
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Purge cassettes are components used with Impella left ventricular assist devices in high-acuity cardiovascular care. They are deployed in hospital settings and require sterility and precise function.
Generation 1 purge cassettes may leak purge fluid, potentially compromising device performance and patient safety during support.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinicians must halt use of affected cassettes and follow recall procedures to avoid potential device malfunction during support.
Refer to the FDA enforcement report Z-1589-2026 and Abiomed recall communications for detailed identifiers and replacement guidance.
Remedy timelines vary; plans for refunds or replacements will be provided by Abiomed and health systems.
Keep copies of recall notices, GTINs, product codes, batch numbers, and all correspondence with Abiomed.
Product codes and configurations span 15 items, including 0043-0003, 004334, 0043-0002, 004413 (005040), 0046-0011, 0048-0002, 0048-0002-BR, 0048-0014 (inclusive of 0048-0047 and 1000402), 0048-0044, 0048-0047, 1000402, 005060, 0550-0002, 0550-0004, 1000362, with distribution worldwide. GTINs are listed in the recall data. Quantity recalled: 33,107 units.
No injuries or incidents have been reported.
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