Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak
Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a functionality defect in a critical hemostatic component. No illnesses, injuries, or deaths have been reported, meeting the criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific is conducting a removal of specific batches of the iSLEEVE EXPANDABLE Introducer Set (REF H74939349140) due to hemostatic valve leaks. A total of 4,060 devices are affected across multiple batch numbers.
The hemostatic valve is a critical component of the introducer set designed to maintain hemostasis during vascular access procedures. Complaints of valve leaks prompted this device removal.
The affected devices have been distributed worldwide, including to the United States and Canada. Healthcare facilities should verify the batch numbers of devices in their inventory and contact Boston Scientific for device replacement or alternative options.
The recalled product
- Product
- Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,060
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 08714729950660
- Batch Numbers: 31368041
- 31390084
- 31390088
- 31390089
- 31501866
- 31501867
- 31501868
- 31501869
- 31520897
- 31520898
- 31604492
- 31616143
- 31633635
- 31650457
- 31664216
- 31664217
- 31671140
- 31671143
- 31693638
Distribution
Distributed nationwide across the United States.
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