Introducer kits in Impella Pump Set and Axillary Insertion Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
0550-0004 |
Impella Circulatory Support Sys – Introducer Set |
1712617 |
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
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
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