Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006)…
Medical device recall Z-2766-2015. 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 Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). 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
15611295 15624432 15653185 15657827 15675111 15640386 15679748 15684667 15698742 15716330 15736494 15736689 15746782 15711284 15753133 15757057 15760114 15764019 15767450 15768507 15770114 15772280 16635566 16691146 17148680 17628922…
Every code shown here, 2,000 characters
15611295 15624432 15653185 15657827 15675111 15640386 15679748 15684667 15698742 15716330 15736494 15736689 15746782 15711284 15753133 15757057 15760114 15764019 15767450 15768507 15770114 15772280 16635566 16691146 17148680 17628922 16675497 16723382 16731675 16738582 16740109 16752661 16760782 16880335 16897923 16904754 16751834 16893570 16894795 16933430 16937185 16940509 16943256 17038874 17041892 17044130 17046074 17123055 17126755 17127496 17133735 17138028 17206369 17210088 17211902 17214752 17218900 17296059 17300015 17388374 17388375 17388376 17388377 17453643 17453644 17708567 17708568 17708569 17708570 18014966 18014967 18014968 18075932 18075933 18075934 18075935 18110488 18204409 18204410 18204411 F00548801 F00548802 F00548803 F00548804 F00548805 F00548806 F00548807 F00548808 F00548809 F00548810 F00548811 F00548812 F00548813 F00548814 F00548815 F00548816 F00548817 F00548818 F00548819 F00548820 F00548821 F00548901 F00548902 F00548903 F00548904 F00548905 F00548906 F00548907 F00548908 F00548909 F00548910 F00548911 F00548912 F00548913 F00548914 F00548915 F00548916 F00548917 F00548918 F00548919 F00548920 F00548921 F00549001 F00549002 F00549003 F00549004 F00549005 F00549006 F00549007 F00549008 F00549009 F00549010 F00549011 F00549012 F00549013 F00549014 F00549015 F00549016 F00549017 F00549018 F00549019 F00549101 F00549102 F00549103 F00549104 F00549105 F00549106 F00549107 F00549108 F00549109 F00549110 F00549111 F00549112 F00549113 F00549114 F00549115 F00549116 F00549117 F00549118 F00549119 F00549120 F00549121 F00549122 F00549123 F00549124 F00549125 F00549126 F00549127 F00549128 F00549130 F00550301 F00550302 F00550303 F00550304 F00550305 F00550306 F00550307 F00550308 F00550309 F00550310 F00550311 F00550312 F00550313 F00550314 F00550315 F00550316 F00550317 F00550318 F00550319 F00550320 F00550321 F00550401 F00550402 F00550403 F00550404 F00550405 F00550406 F00550407 F00550408 F00550409 F00550410 F00550411 F00550412 F00550413 F00550414 F00550415 F00550416 F00550417…
FDA’s list runs to 10,080 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 10,080 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.