FDA Medical devices recall ·
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the… recall
- Recall number
- Z-2754-2026
- Date
- (initiated June 11, 2026)
- Company / brand
- Boston Scientific Corporation
4100 Hamline Ave N, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 400 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153
Distribution
Global Distribution. US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2754-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.