Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F (…
Medical device recall Z-2765-2015. Published in FDA’s Enforcement Report on Sep 23, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 23, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 29,169 units total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
29,169 units total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,992 characters
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 15906797 15913993 15918189 17505941 15921282 15927421 15931041 15934213 15935418 15942659 15955253 15957982 15965734 15972756 15980369 17514542 17516996 17517162 17517166 15989303 15990230 15992405 15996022 16018190 16022222 16039472 16063043 16069159 16081852 16095359 16102740 16125461 16135272 16138323 16151320 16168784 16172940 16180118 16190833 16208087 16228219 16239134 16242466 16245796 16271044 16274328 16284579 16297407 16326970 16330055 16337479 16342271 17505943 17522735 16410910 16457878 16459272 16511473 16528429 16535544 16547561 16566477 16586724 16601179 16605567 16611630 16615630 16626168 16669688 16676235 16684501 16691147 16706057 17505944 16709410 16714136 16719785 16743850 16772082 16783761 16794223 16799658 16807375 16811004 16812948 16820799 16826393 16835331 16858003 16860706 16875092 16919733 16927173 16931941 16946166 16957819 16984103 17015190 17016764 17031819 17053901 17088542 17588070 17158555 17161831 17162162 17162163 17162164 17174212 17190029 17193307 17256409 17265820 17271026 17274694 17281586 17282611 17308887 17331530 17337336 17368985…
FDA’s list runs to 14,672 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, White Russia.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 25, 2015.
- FDA classified it on Sep 15, 2015.
- FDA’s Enforcement Report published it on Sep 23, 2015.
- FDA terminated it on Apr 4, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Maple Grove, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 14,672 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.