Abiomed Purge Cassette Generation 1 for Impella — recall 81683
Health Canada — Medical Devices · Canada · 2026-03-04 · Type I
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General hospital and personal use - Cardiovascular
Product type
Medical devices
Reported risk: Abiomed, Inc. has issued a voluntary device recall (removal) of Purge Cassette (Generation 1) due to an increased risk of purge leaks. An updated Purge Cassette (Generation 2) has been developed with a lower risk of purge leaks. Abiomed is coordinating the product removal and replacement process. In the interim, when using a Generation 1 Purge Cassette Abiomed advises closely monitoring the Purge System and consulting the IFU should a 'Purge Pressure Low' alarm occur.
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