Z-2757-2026Class II

FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of...

Name: Z-2757-2026 FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of...
Creator: Boston Scientific Corporation
Published: 2026-06-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-06-11 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU... on 2026-06-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2757-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-11
Posted: 2026-07-20
Recalling firm: Boston Scientific Corporation
Product: FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
Product code: DRA Catheter, Steerable
Reason for recall: 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.
FDA 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 [email protected] 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 in commerce: 193,000 units
Distribution: Global Distribution. US Nationwide.
Product codes and lots: UDI-DI: 00191506042516; Lots: CL12917, CL13004, CL13017, CL13046, CL13060, CL13080, CL13103, CL13122, CL13123, CL13142, CL13160, CL13196, CL13212, CL13219, CL13231, CL13260, CL13291, CL13340, CL13375, CL13401, CL13422, CL13468, CL13519, CL13573, CL13578, CL13614, CL13646, CL13670, CL13671, CL13708, CL13719, CL13722, CL13732, CL13760, CL13801, CL13802, CL13820, CL13833, CL13856, CL13910, CL13911, CL13925, CL13940, CL13971, CL13972, CL13988, CL14025, CL14039, CL14050, CL14051, CL14076, CL14077, CL14119, CL14120, CL14135, CL14137, CL14171, CL14187, CL14226, CL14249, CL14286, CL14287, CL14345, CL14346, CL14375, CL14376, CL14396, CL14397, CL14439, CL14488, CL14500, CL14501, CL14518, CL14519, CL14581, CL14582, CL14633, CL14635, CL14670, CL14697, CL14711, CL14749, CL14750, CL14769, CL14770, CL14813, CL14814, CL14854, CL14855, CL14870, CL14871, CL14928, CL14929, CL14933, CL14934, CL14935, CL14968, CL14969, CL15005, CL15009, CL15067, CL15107, CL15108, CL15109, CL15128, CL15129, CL15191, CL15192, CL15193, CL15239, CL15240, CL15272, CL15318, CL15358, CL15397, CL15427, CL15474, CL15490, CL15539, CL15568, CL15569, CL15597, CL15598, CL15637, CL15638, CL15640, CL15754, CL15755, CL15775, CL15776, CL15808

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2757-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2754-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17
Z-2755-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17
Z-2756-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17
Z-2757-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17

Product code DRA

K233248Class IIFARADRIVE™ Steerable SheathBoston Scientific Corporation / cleared 2023-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)