FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
- Recall number
- Z-2755-2026
- Recalling firm
- Boston Scientific Corporation
- Product
- FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
- Status
- Open, Classified
- Initiated
- 2026-06-11
- Posted
- 2026-07-20
- Terminated
- not on file
- Reason
- Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- Root cause
- Use error
- Action
- An Important Medical Device Product Advisory notification letter dated 6/11/26 was sent to customers. Actions " Follow the revised IFU provided in Appendix 1. " Forward this notice to relevant personnel and any facilities to which the product was transferred. " Complete and return the enclosed Acknowledgement Form. " Report any adverse events or quality concerns associated with use of these devices to Boston Scientific via email at BSCComplaints@bsci.com or FDA s MedWatch Adverse Event Reporting program [www.fda.gov/MedWatch/report.htm or 1.800.FDA.1088 (332.1088)]. If you require additional assistance or more information regarding this communication, please contact your local Boston Scientific representative.
- Quantity
- 74,760 units
- Distribution
- Global Distribution. US Nationwide.
- Lot, serial or model codes
- UDI-DI: 00810087180072; Lots: CL12697, CL12698, CL12701, CL12702, CL12824, CL12832, CL12833, CL12861, CL12888, CL12889, CL12912, CL12913, CL12916, CL12918, CL12968, CL12975, CL12977, CL13003, CL13016, CL13019, CL13045, CL13047, CL13059, CL13078, CL13079, CL13101, CL13102, CL13120, CL13121, CL13140, CL13141, CL13158, CL13159, CL13195, CL13211, CL13218, CL13232, CL13233, CL13259, CL13290, CL13339, CL13367, CL13400, CL13421, CL13516, CL13518, CL13572, CL13577, CL13615, CL13645, CL13669, CL13707, CL13720, CL13733, CL13821, CL13834, CL13857, CL13926, CL13941, CL13976, CL13989, CL14026, CL14052, CL14078, CL14121, CL14138, CL14170, CL14186, CL14225, CL14248, CL14285, CL14344, CL14352, CL14374, CL14395, CL14438, CL14487, CL14499, CL14517, CL14580, CL14632, CL14669, CL14690, CL14710, CL14748, CL14768, CL14967, CL15004, CL15008, CL15066, CL15106, CL15127, CL15190, CL15238, CL15271, CL15317, CL15357, CL15396, CL15426, CL15473, CL15489, CL15567, CL15636, CL15639, CL15753, CL15774, CL15807
- 510(k) numbers
- ["K233248"]
- PMA numbers
- not on file
- Product code
- DRA
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28