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The official notice did not include a photo. Check the product details and identifiers below.
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Isleeve™ expandable introducer set
Official notice
29 Feb 2024
An official Health Canada notice concerns Isleeve™ expandable introducer set. Boston Scientific is conducting a removal of specific batches of the iSLEEVE™ 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak. Our internal investigation has concluded that the hemostatic valve seals were more likely to leak as a result of a manufacturing nonconformance, related only to these batches. Recall start date: February 20, 2024 Published 2024-02-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75160
Official notice
2024-02-29
The hazard
The hazard
Boston Scientific is conducting a removal of specific batches of the iSLEEVE™ 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak. Our internal investigation has concluded that the hemostatic valve seals were more likely to leak as a result of a manufacturing nonconformance, related only to these batches. Recall start date: February 20, 2024
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.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
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: Boston Scientific, Isleeve™ Expandable Introducer Set.
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.
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