Abiomed Purge Cassette Generation 1 for Impella
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Purge Cassette, 5 Pack |
More than 10 numbers, contact manufacturer. |
0043-0003 |
Impella CP Smart Assist Set (includes Generation 1 Purge Cassette) |
More than 10 numbers, contact manufacturer. |
0048-0044 |
Impella 5.5 With SmartAssist Set (includes Generation 1 Purge Cassette) |
More than 10 numbers, contact manufacturer. |
0550-0004 |
Issue
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.
Additional information
Details
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
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