Impella Products
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
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