Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
FDA device recall Z-1390-2024 · posted 2024-03-28 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 4060 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada.
- Date initiated
- 2024-02-20
- Date posted
- 2024-03-28
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 14F iSLEEVE Introducer Set (K233503) | Boston Scientific Corporation | 2023-11-30 |
| 14F iSLEEVE™ Introducer Set (K230051) | Boston Scientific Corporation | 2023-02-03 |
| 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (K191871) | Boston Scientific Corporation | 2019-08-07 |
| iSLEEVE Introducer Set (K180785) | Boston Scientific Corporation | 2018-06-22 |