Impella Products
Brand(s)
Last updated
Summary
Product
Impella Products
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| Impella CP | All lots. | 0048-0004 |
| Impella 5.0 | All lots. | 005064 |
| Impella CP With Smart Assist | All lots. | 0048-0044 |
| Impella 5.5 With Smart Assist | All lots. | 0550-0004 |
Issue
New warnings are being added to the instructions for use for affected products to reduce the possibility of fibers being drawn into the Impella pumps, which may result in low flow of the device.
Recall Start Date: February 26, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75219
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