CanadaAbiomed Purge Cassette Generation 1 for Impella is affected — sold as Purge Cassette, 5 Pack (model 0043-0003) and included in Impella CP Smart Assist Set (0048-0044) and Impella 5.5 With SmartAssist Set (0550-0004); affected lot/serial numbers are listed as “more than 10 numbers,” contact the manufacturer for specifics. The product was recalled due to an increased risk of purge leaks; Abiomed has developed a Generation 2 cassette and is coordinating removal and replacement. In the interim Abiomed advises closely monitoring the Purge System, consulting the IFU if a “Purge Pressure Low” alarm occurs, and contacting the manufacturer for additional information.
What's being recalled
Companies: Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.
How to identify it
Affected products: Purge Cassette, 5 Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0043-0003
Affected products: Impella CP Smart Assist Set (includes Generation 1 Purge Cassette); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0048-0044
Affected products: Impella 5.5 With SmartAssist Set (includes Generation 1 Purge Cassette); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0550-0004
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)