Recall MonitorHealth ProductsType I recall
Abiomed Purge Cassette Generation 1 for Impella
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use, Health products - Medical devices - Cardiovascular
Product: Abiomed Purge Cassette Generation 1 for Impella
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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.