Boston Scientific — Class II medical device recall Z-2765-2015
Terminated recall by Boston Scientific Corporation, reported 2015-09-23, distributed nationwide. Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preve
| Recall number | Z-2765-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2015-08-25 |
| Classified | 2015-09-15 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-04-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IR, IT, KR, KW, LB, MX, MY, NL, NZ, OM, PA, PH, PL, PT, RO, RS, RU, SA, SE, SG, SI, TH, TN, TR, TW, ZA |
| Quantity | 29,169 units |
| Reason classes | packaging |
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.
Reason for recall
Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2765-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.