Recall Z-1390-2024 · DYB Introducer, Catheter
Boston Scientific Corporation
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
| Date | Mar 28, 2024 (initiated Feb 20, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 4060 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180785 | iSLEEVE Introducer Set Boston Scientific Corporation, Jun 22, 2018 |
| K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set Boston Scientific Corporation, Aug 7, 2019 |
| K230051 | 14F iSLEEVE Introducer Set Boston Scientific Corporation, Feb 3, 2023 |
| K233503 | 14F iSLEEVE Introducer Set Boston Scientific Corporation, Nov 30, 2023 |