Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Recall
- Recall Number
- Z-1390-2024
- Event Number
- 94041
- Firm
- Boston Scientific Corporation
- FEI Number
- 3002095335
- Product Code
- DYB
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- February 20, 2024
- Posted
- March 28, 2024
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565
Description
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
Boston Scientific issued an Urgent Field Safety Notice - Medical Device Product Removal to its consignees on 02/20/2027 via FedEx. The notice explained the problem with the device, potential risk, and requested the following: 1. Immediately discontinue use and segregate the affected product. 2. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. 3. Once Boston Scientific receives your completed RVTF, you will be contacted within 2 business days and provided an RGA number for product return. For questions, contact your local Boston Scientific representative.
Worldwide distribution - US Nationwide and the countries of Canada.
4060 devices