TruSeal single access systems recalled over transseptal air ingress risk
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, OUS, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this transseptal access system action as Class I.
Plain-English summary
The WATCHMAN TruSeal Access System SGL, OUS, material number M635TS70010, GTIN 08714729965732, is being recalled across all non-expired batches. The system is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure devices with delivery systems. The recall covers 340,185 units in total, distributed worldwide.
Boston Scientific identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. The company states that, according to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium under conscious or deep sedation, patients have an approximately three times higher risk in a US study of negative left atrium pressure and air ingress. The FDA classified the action as Class I, its most serious category.
Hospitals and proceduralists should follow the manufacturer's updated instructions on ventilation during these procedures.
The recalled product
- Product
- WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Access
- Hazard
- air-embolism
- transseptal-access
- ventilation
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 08714729965732
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
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