Impella Products recall in Canada: labeling and packaging issue
In plain language
This recall involves Impella medical devices sold in Canada. New warnings are being added to the instructions for use to reduce the possibility of fibers being drawn into the pumps, which may result in low flow of the device. This recall is for healthcare professionals. Contact the manufacturer if you require additional information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
Impella CP
Model: 0048-0004
Lot: All lots
Impella 5.0
Model: 005064
Lot: All lots
Impella CP With Smart Assist
Model: 0048-0044
Lot: All lots
Impella 5.5 With Smart Assist
Model: 0550-0004
Lot: All lots
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 0048-0004, 0048-0044, 005064, 0550-0004
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves Impella medical devices sold in Canada. New warnings are being added to the instructions for use to reduce the possibility of fibers being drawn into the pumps, which may result in low flow of the device. This recall is for healthcare professionals. Contact the manufacturer if you require additional information.
What should consumers do?
Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on March 12, 2024.
Is the Abiomed Inc. brand affected by this recall?
Yes, Abiomed Inc. products are affected by this recall. This recall involves Impella medical devices sold in Canada. New warnings are being added to the instructions for use to reduce the possibility of fibers being drawn into the pumps, which may result in low flow of the device. This recall is for healthcare professionals. Contact the manufacturer if you require additional information.