iSLEEVE™ Expandable Introducer Set
Brand(s)
Last updated
Summary
Product
iSLEEVE™ Expandable Introducer Set
Issue
Medical devices - Performance
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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