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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- 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
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
Similar recalls
- SevereBoston Scientific steerable sheath devices recalled due to manufacturing defect risk
FDA (Devices) · 2024-04-03
- SevereBoston Scientific Z Flex 270 Steerable Sheath Recalled for Embolic Risk
FDA (Devices) · 2012-10-03
- SevereBoston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation
FDA (Devices) · 2015-12-30
- HighBoston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk
FDA (Devices) · 2015-09-23
- SevereBoston Scientific Cardiac Catheters Recalled for Inner Lining Delamination
FDA (Devices) · 2024-05-22
- SevereExpo 5F Selective Angiographic Catheters recalled due to material delamination
FDA (Devices) · 2024-05-22