No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
No image published for this recall
Abiomed introducer kits with impella heart pumps
Official notice
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 product name and identifiers below with the item you own. Follow the official notice if they match.
Skus
Other
Model Numbers
Recall Numbers
Checked manually this time?
The app alerts you when a new official recall is published — no searching, no checking back.
Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
Product 8
Product 9
Product 10
Product 11
Product 12
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Abiomed.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
View full official noticeRelated recalls
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Automated impella® controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Abiomed purge cassette generation 1 for impella
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Automated impella controller
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Automated impella® controller
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella® controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella® controller
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella products
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Introducer kits in impella pump set and axillary insertion kit
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella cp with smartassist and impella 5.5 with smartassist
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella cp
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Automated impella® controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Abiomed purge cassette generation 1 for impella
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Automated impella controller
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Automated impella® controller
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella® controller
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella® controller
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Impella products
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Introducer kits in impella pump set and axillary insertion kit
Brand match
Medium risk
Markets
Weekly recall digest
Get next week's recalls before you need them.
One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.
The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.
This recall was published 29 Jun 2026. The next one won't wait for you to search.
RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.
