CanadaAbiomed Introducer Kits and the listed Impella pump sets (all lots; examples of model/catalogue numbers include 0052‑0039, 1000550, 0052‑0038, 0052‑0002, 1000441, 1000323, 2000342, 0052‑0011, 0052‑0011‑CA, 0550‑0004, 1000551, 0048‑0044) are affected. They were recalled because the introducer sheath may unexpectedly leak from the sidearm, under the sheath cap and along the hub score lines, which may impair hemostasis and increase the risk of access‑site bleeding, particularly in anticoagulated patients. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.
How to identify it
Affected products: Impella CP Introducer Kit; Lot or serial number: All lots.; Model or catalogue number: 0052-0039
Affected products: Impella CP Introducer Kit; Lot or serial number: All lots.; Model or catalogue number: 1000550
Affected products: Impella CP Introducer Kit; Lot or serial number: All lots.; Model or catalogue number: 0052-0038
Affected products: Introducer Kit 23 Fr For Impella RP; Lot or serial number: All lots.; Model or catalogue number: 0052-0002
Affected products: Impella RP Flex With Smartassist Pump Set; Lot or serial number: All lots.; Model or catalogue number: 1000441
Affected products: Impella RP Flex With Smartassist Pump Set; Lot or serial number: All lots.; Model or catalogue number: 1000323
Affected products: Impella RP Flex With Smartassist Pump Set; Lot or serial number: All lots.; Model or catalogue number: 2000342
Affected products: Axillary Insertion Kit; Lot or serial number: All lots.; Model or catalogue number: 0052-0011
Affected products: Axillary Insertion Kit; Lot or serial number: All lots.; Model or catalogue number: 0052-0011-CA
Affected products: Impella 5.5 Set With Smartassist; Lot or serial number: All lots.; Model or catalogue number: 0550-0004
Affected products: Impella 5.5 Set With Smartassist; Lot or serial number: All lots.; Model or catalogue number: 1000551
Affected products: Impella CP Smart Assist Set, Canada; Lot or serial number: All lots.; Model or catalogue number: 0048-0044
The hazard
Abiomed has initiated a voluntary medical device recall (correction) for all currently distributed Introducer kits that are used with Impella heart pumps to notify customers of a potential for unexpected introducer sheath leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region. Introducer leakage may impair hemostasis and increase the risk of access-site bleeding, particularly in anticoagulated patients. This information is provided to support appropriate clinical awareness, monitoring, and patient support as needed. The identified defect does not affect any other packaged products within the pump set.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)