FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mater
Summary
The FDA issued a Class II for FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature a by Boston Scientific Corporation. Reason: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage relat.
Details
Source
Device Recall
External ID
Z-2755-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI-DI: 00810087180072; Lots: 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, CL13339, CL13367, CL13400, CL13421, CL13516, CL13518, CL13572, CL13577, CL13615, CL13645, CL13669, CL13707, CL13720, CL13733, CL13821, CL13834, CL13857, CL13926, CL13941, CL13976, CL13989, CL14026, CL14052, CL14078, CL14121, CL14138, CL14170, CL14186, CL14225, CL14248, CL14285, CL14344, CL14352, CL14374, CL14395, CL14438, CL14487, CL14499, CL14517, CL14580, CL14632, CL14669, CL14690, CL14710, CL14748, CL14768, CL14967, CL15004, CL15008, CL15066, CL15106, CL15127, CL15190, CL15238, CL15271, CL15317, CL15357, CL15396, CL15426, CL15473, CL15489, CL15567, CL15636, CL15639, CL15753, CL15774, CL15807
Quantity Affected: 74,760 units
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.
Distribution
Global Distribution. US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-11
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Boston Scientific Corporation has 414 FDA actions in our database, including 345 recalls and 69 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 414 FDA actions in our database, including 345 recalls and 69 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2755-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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