Health product recall

iSLEEVE™ Expandable Introducer Set

Last updated

Summary

Product
iSLEEVE™ Expandable Introducer Set
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
iSLEEVE™ Expandable Introducer Set More than 10 numbers, contact manufacturer. H74939349140

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Boston Scientific Corporation

300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75160

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