Introducer kits in Impella Pump Set and Axillary Insertion Kit
In plain language
This recall involves introducer kits used in Impella Pump Sets and Axillary Insertion Kits sold in Canada. They are being recalled because the packaging may be damaged, which could compromise the sterile barrier. Stop using the product and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer if you require additional information.
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Affected products
Impella Circulatory Support Sys – Impella CP Left Ventricle Percutaneous Catheter Pump
Model: 0048-0004
Lot: 2023168715
Impella Circulatory Support System – Impella CP With Smart Assist
Model: 0048-0044
Lot: More than 10 numbers, contact manufacturer.
Impella Circulatory Support System – LP5.0 Set
Model: 005064
Lot: More than 10 numbers, contact manufacturer.
Impella 5.5 Set With SmartAssist
Model: 0550-0004
Lot: 2024341586, 2024356969, 2024338391, 2024341579, 2024356971, 2024338394
Impella Circulatory Support Sys – Introducer Set
Model: 0052-0001
Lot: 1712617, 1578896, 1635076, 1688923, 1651258
Axillary Insertion Kit For Impella 5.0
Model: 0052-0011
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Compromised sterile barrier due to packaging damage
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: 1712617, 1578896, 1635076, 1688923, 1651258, 2023168715, 2024341586, 2024356969, 2024338391, 2024341579, 2024356971, 2024338394, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 0048-0004, 0048-0044, 005064, 0052-0001, 0052-0011, 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?
Compromised sterile barrier due to packaging damage
What should consumers do?
Stop using the product immediately. 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?
Yes, there may be a health risk. Compromised sterile barrier due to packaging damage
When was this product recalled?
This product was recalled on December 21, 2023.
Is the Abiomed Inc. brand affected by this recall?
Yes, Abiomed Inc. products are affected by this recall. This recall involves introducer kits used in Impella Pump Sets and Axillary Insertion Kits sold in Canada. They are being recalled because the packaging may be damaged, which could compromise the sterile barrier. Stop using the product and contact the manufacturer for more information.