Boston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk
Boston Scientific is recalling FARADRIVE STEERABLE SHEATH (CLEAR) because improper dilator insertion can damage the hemostatic valve, potentially leading to air ingress and air embolism.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious injury (air embolism) resulting from a device defect.
Plain-English summary
Boston Scientific Corporation is recalling FARADRIVE STEERABLE SHEATH (CLEAR) - US. This device is used to facilitate access to the vasculature and into the chambers of the heart.
Investigations into complaints have identified that improper dilator insertion orientation during device preparation can cause damage to the hemostatic valve. This damage may result in air ingress, which poses a risk of air embolism and associated patient harm.
To mitigate this risk, the dilator must be inserted straight through the center of the valve and fully advanced into the sheath body.
The recalled product
- Product
- FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Vascular Access
- Affected units
- 508,151
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00191506043131
- Lots: CL12695
- CL12696
- CL12699
- CL12700
- CL12703
- CL12808
- CL12816
- CL12817
- CL12823
- CL12834
- CL12835
- CL12836
- CL12853
- CL12860
- CL12882
- CL12883
- CL12884
- CL12891
- CL12907
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
Same hazard · air embolism
See all →- HighBoston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage
FDA (Devices) · 2026-07-29
- HighFARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall
FDA (Devices) · 2026-07-29
- HighFARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk
FDA (Devices) · 2026-07-29
- SevereMedical Angiographic Control Syringes Recalled for Rotating Adapter Risk
FDA (Devices) · 2026-05-20
- CriticalB. Braun Hemodialysis Bloodlines Recalled Due to Potential Air Bubble Accumulation
FDA (Devices) · 2026-04-22