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Abiomed introducer kits with impella heart pumps
Official notice
29 Jun 2026
Last checked
29 Jun 2026
An official Health Canada notice concerns Abiomed introducer kits with impella heart pumps. 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. Published 2026-06-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
82261
Official notice
2026-06-29
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Affected area 1
Company & contacts
Company & contacts
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Brand: Abiomed.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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