Introducer kits in Impella Pump Set and Axillary Insertion Kit
Brand(s)
Last updated
Summary
Product
Introducer kits in Impella Pump Set and Axillary Insertion Kit
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 Circulatory Support Sys – Impella CP Left Ventricle Percutaneous Catheter Pump | 2023168715 | 0048-0004 |
| Impella Circulatory Support System – Impella CP With Smart Assist | More than 10 numbers, contact manufacturer. | 0048-0044 |
| Impella Circulatory Support System – LP5.0 Set | More than 10 numbers, contact manufacturer. | 005064 |
| Impella 5.5 Set With SmartAssist | 2024341586 2024356969 2024338391 2024341579 2024356971 2024338394 | 0550-0004 |
| Impella Circulatory Support Sys – Introducer Set | 1712617 1578896 1635076 1688923 1651258 | 0052-0001 |
| Axillary Insertion Kit For Impella 5.0 | More than 10 numbers, contact manufacturer. | 0052-0011 |
Issue
There is a potential risk of packaging damage for introducer kits which may compromise the sterile barrier. There have been no reported complaints for this type of damage and this issue was found in <0.6% of all introducer kits that was received. The following introducer kit identifiers, 0052-3006, 0052-3046, 0052-3014, 0052-3025, 0052-3052 which are part of the Impella pump sets and insertion kits are affected by the recall action.
Recall Start Date: December 11, 2023
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-74772
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