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FDA recall, , Moderate risk

Boston Scientific FARADRIVE Steerable Sheath Clear

The FARADRIVE Steerable Sheath Clear can have valve damage that may cause air ingress and potential air embolism.

Summary by Recall Canary from the FDA notice

What happened

Boston Scientific Corporation of Saint Paul, Minnesota, is recalling the FARADRIVE Steerable Sheath Clear and related models, used to facilitate access to the vasculature and into the chambers of the heart.

The agency states that complaint investigations 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.

The recall began June 11, 2026, and the FDA classified it July 17, 2026, with the notice added to the Enforcement Report July 20, 2026. Distribution was nationwide in the U.S. and global. The risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

More device defect recalls

What to do

If yours is listed below, or you can't tell:

  1. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

Is yours affected?

Match the UDI-DI and lot code listed under your product.

Incomplete list: 123 of 567 lot codes shown.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. FARADRIVE Steerable Sheath Clear, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062

    UDI-DI
    • 00810087180072
    Lot code
    • CL12697
    • CL12698
    • CL12701
    • CL12702
    • CL12824
    • CL12832
    • CL12833
    • CL12861
    • CL12888
    • CL12889
    • CL12912
    • CL12913
    • CL12916
    • CL12918
    • CL12968
    • CL12975
    • CL12977
    • CL13003
    • CL13016
    • CL13019
    • CL13045
    • CL13047
    • CL13059
    • CL13078
    • CL13079
    • CL13101
    • CL13102
    • CL13120
    • CL13121
    • CL13140
    • CL13141
    • CL13158
    • CL13159
    • CL13195
    • CL13211
    • CL13218
    • CL13232
    • CL13233
    • CL13259
    • CL13290

  2. 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

    UDI-DI
    • 00191506042516
    Lot code
    • CL12917
    • CL13004
    • CL13017
    • CL13046
    • CL13060
    • CL13080
    • CL13103
    • CL13122
    • CL13123
    • CL13142
    • CL13160
    • CL13196
    • CL13212
    • CL13219
    • CL13231
    • CL13260
    • CL13291
    • CL13340
    • CL13375
    • CL13401
    • CL13422
    • CL13468
    • CL13519
    • CL13573
    • CL13578
    • CL13614
    • CL13646
    • CL13670
    • CL13671
    • CL13708
    • CL13719
    • CL13722
    • CL13732
    • CL13760
    • CL13801
    • CL13802
    • CL13820
    • CL13833
    • CL13856
    • CL13910

  3. 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

    UDI-DI
    • 00191506043131
    Lot code
    • CL12695
    • CL12696
    • CL12699
    • CL12700
    • CL12703
    • CL12808
    • CL12816
    • CL12817
    • CL12823
    • CL12834
    • CL12835
    • CL12836
    • CL12853
    • CL12860
    • CL12882
    • CL12883
    • CL12884
    • CL12891
    • CL12907
    • CL12908
    • CL12909
    • CL12919
    • CL12949
    • CL12950
    • CL12969
    • CL12976
    • CL12979
    • CL12980
    • CL13005
    • CL13010
    • CL13011
    • CL13012
    • CL13018
    • CL13032
    • CL13033
    • CL13034
    • CL13037
    • CL13056
    • CL13057
    • CL13058

  4. 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

    UDI-DI
    • 00810087181062
    Lot code
    • CL12910
    • CL12978
    • CL15153

Recall details

Company began the recall
Sold in

Global Distribution. US Nationwide.

Company
Boston Scientific CorporationSaint Paul, Minnesota
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99252
Recall numbers
Z-2754-2026 to Z-2757-2026

All recalls from Boston Scientific Corporation

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Classified by FDA

  3. Added to FDA's Enforcement Report

  4. Listed on Recall Canary

  5. In FDA's weekly enforcement report

  6. Summary updated

Other device defect recalls

See all: Other device defect recalls

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)