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

Lot, batch or date codesUDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153

Quantity recalled400 units

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.

Nationwide

Questions about this recall

Is Faradrive Steerable Sheath Clear IDE, used to facilitate access to the vasculature and recalled?

Yes. Boston Scientific recalled Faradrive Steerable Sheath Clear IDE, used to facilitate access to the vasculature and on 11 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2754-2026.

Why was it recalled?

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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