TruSeal DBL access systems recalled over air embolism risk without ventilation
Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 DBL, US, material number M635TU70020, GTIN 08714729965718, 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 DBL, US, Material Number (UPN) M635TU70020; 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
- Affected units
- 340,185
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 08714729965718
- ALL NON-EXPIRED BATCHES
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 11 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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