Recall MonitorHealth ProductsType I recall
Abiomed Introducer Kits with Impella Heart Pumps
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Abiomed Introducer Kits with Impella Heart Pumps
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Impella CP Introducer Kit | All lots. | 0052-0039 |
| Impella CP Introducer Kit | All lots. | 1000550 |
| Impella CP Introducer Kit | All lots. | 0052-0038 |
| Introducer Kit 23 Fr For Impella RP | All lots. | 0052-0002 |
| Impella RP Flex With Smartassist Pump Set | All lots. | 1000441 |
| Impella RP Flex With Smartassist Pump Set | All lots. | 1000323 |
| Impella RP Flex With Smartassist Pump Set | All lots. | 2000342 |
| Axillary Insertion Kit | All lots. | 0052-0011 |
| Axillary Insertion Kit | All lots. | 0052-0011-CA |
| Impella 5.5 Set With Smartassist | All lots. | 0550-0004 |
| Impella 5.5 Set With Smartassist | All lots. | 1000551 |
| Impella CP Smart Assist Set, Canada | All lots. | 0048-0044 |
Issue
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.