CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
Faradrive Steerable Sheath Clear IDE recalled by Boston Scientific
Boston Scientific is recalling Faradrive Steerable Sheath Clear IDE, used to facilitate access to the vasculature and, distributed nationwide in the US. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2754-2026
- FDA event ID
- 99252
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2026
- FDA classified
- 17 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Jun 2026 | Recall initiated by company | |
| 17 Jul 2026 | Classified by FDA | +36 days |
| 29 Jul 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Global Distribution. US Nationwide.
Questions about this recall
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.
Which lots are affected?
UDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153
Where was it sold?
Global Distribution. US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99252This product is part of a recall event; the main page for the event is Faradrive Steerable Sheath Clear recalled by Boston Scientific.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Faradrive Steerable Sheath Clear recalled by Boston Scientific | Boston Scientific | Other | Nationwide | |
| CLASS II | Faradrive Steerable Sheath Clear Ous recalled by Boston Scientific | Boston Scientific | Other | Nationwide | |
| CLASS II | Faradrive Steerable Sheath (Clear) - US recalled by Boston Scientific | Boston Scientific | Other | Nationwide |
More recalls from Boston Scientific
All 628| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | StoneSmart Connect Console Contents: Power Cord recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |