FDA Device recall Z-2765-2015
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU…
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU… by Boston Scientific, citing 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 Correc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2765-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-25 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
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.
Identifiers
| code_info | 16752208 16891755 17138030 17211903 17214753 17296669 17395755 17483898 17712231 18053939 18120336 F00541702…16752208 16891755 17138030 17211903 17214753 17296669 17395755 17483898 17712231 18053939 18120336 F00541702 F00541703 F00541707 F00541708 F00541709 F00541903 F00541904 F00541905 F00541906 F00541907 F00541908 F00541909 F00541913 F00541914 F00541916 F00544503 F00544504 F00544505 F00544508 F00544509 F00544511 F00544703 F00544704 F00544706 F00544707 F00544709 F00544710 F00545201 F00547501 F00547502 F00547505 F00547506 F00547507 F00547508 F00547509 F00547510 F00547511 F00547512 F00547514 F00548202 F00548204 F00548205 F00548206 F00548207 F00548210 F00548211 F00548213 F00548215 15513009 15556842 15559607 15559608 15573287 15576411 15579547 15583022 15586521 15597796 15608021 15634208 15639752 15645828 15648179 15650910 15664113 15688025 15694584 15711219 15719185 15722025 15746165 15760115 15767309 15791346 15798829 15802896 15802971 17514543 15846552 15851185 15859123 15870174 15883167 15889808 15 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2765-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.