Boston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk
Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (undesired blood leakage) due to a device malfunction, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the criteria for a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling the WATCHMAN Access System Access Sheath with Dilator, 14F Single curve, 14F Double curve, and 14F Anterior curve. The recall involves 29,169 units distributed worldwide, including the United States and numerous international markets.
The recall is issued because cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place. This defect may prevent the valve from sealing properly when desired, which could lead to undesired blood leakage. The field correction reinforces the Directions for Use and provides guidance on the correct use of the hemostasis valve to avoid cross-threading and ensure the valve seals securely.
Healthcare providers and facilities that have received these devices should stop using them and follow the instructions provided by Boston Scientific for the field correction. The correction is intended to minimize the potential for undesired blood leakage by ensuring the valve is used correctly.
The recalled product
- Product
- Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Access
- Affected units
- 29,169
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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