Impella Systems
Brand(s)
Last updated
Summary
Product
Impella Systems
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 catalogue number |
|---|---|---|
| Impella 5.0 | All lots. | 005064 |
| Impella 5.5 With Smart Assist | All lots. | 0550-0004 |
| Impella Cp | All lots. | 0048-0004 |
| Impella Cp With Smart Assist | All lots. | 0048-0044 |
Issue
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
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 I
Identification number
RA-75182
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