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Open, Classified

Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system

FDA Recall Z-1390-2024 · Posted 2024-03-28

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2024-02-20
Product Quantity4060 devices

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K23350314F iSLEEVE Introducer SetBoston Scientific Corporation · 2023-11-30K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation · 2023-02-03K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019-08-07K180785iSLEEVE Introducer SetBoston Scientific Corporation · 2018-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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