Quick Facts at a Glance
- Recall Date
- June 11, 2026
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Model numbers
- UDI-DI: 00191506042516, Lots: CL12917, CL13004, CL13017, CL13046, CL13060, CL13080, CL13103 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 11, 2026
Reported by FDA DEVICE
July 29, 2026
RecallRadar source check
August 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. 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.. Classification: Class II. Quantity: 193,000 units. Distribution: Global Distribution. US Nationwide.
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Safety Guide
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