Boston Scientific WATCHMAN Device Field Correction for Hemostasis Valve Cross-Thread Risk
Boston Scientific is issuing a field correction for WATCHMAN Left Atrial Appendage Closure Devices to prevent hemostasis valve cross-threading and potential blood leakage.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a procedural risk (cross-threading) that could lead to blood leakage, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary correction.
Plain-English summary
Boston Scientific Corporation is issuing a field correction for the WATCHMAN Left Atrial Appendage Closure Device with Delivery System. The affected sizes are 21mm x 12F, 24mm x 12F, 27mm x 12F, 30mm x 12F, and 33mm x 12F. A total of 29,169 units are involved in this action.
The recall is due to a risk of cross-threading the hemostasis valve if it is tightened with the dilator in place. This issue may prevent the valve from sealing securely, which could lead to undesired blood leakage. The field correction reinforces the Directions for Use and provides additional guidance on the correct use of the hemostasis valve to avoid cross-threading and ensure secure sealing.
The devices were distributed worldwide, including in the United States and numerous international markets. Healthcare providers and facilities should review the field correction instructions to ensure proper handling and use of the hemostasis valve to minimize the potential for blood leakage.
The recalled product
- Product
- Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Device
- 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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