iSLEEVE™ Expandable Introducer Set
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
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