Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM
Medical device recall Z-2169-2016. Published in FDA’s Enforcement Report on Jul 20, 2016.
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 Jul 20, 2016. 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
- 45,302 (8,188 in the U.S.) - total, all model numbers 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?
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
45,302 (8,188 in the U.S.) - total, all model numbers, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MODEL Number: M0035431520: Lot Number/Expiration Date: 18784673 31-Jan-19 18723226 30-Nov-18 18686302 30-Nov-18 18637332 31-Oct-18 18627687 31-Oct-18 18569824 31-Aug-18 18453278 30-Jun-18 18391505 31-May-18 18769932 31-Dec-18 18735994…
Every code shown here, 1,746 characters
MODEL Number: M0035431520: Lot Number/Expiration Date: 18784673 31-Jan-19 18723226 30-Nov-18 18686302 30-Nov-18 18637332 31-Oct-18 18627687 31-Oct-18 18569824 31-Aug-18 18453278 30-Jun-18 18391505 31-May-18 18769932 31-Dec-18 18735994 30-Nov-18 18710356 30-Nov-18 18652851 31-Oct-18 18801847 31-Jan-19 18755945 31-Dec-18 18602481 30-Sep-18 18832966 28-Feb-19 18843005 28-Feb-19 18630099 31-Oct-18 18510994 31-Jul-18 18495363 31-Jul-18 18484141 31-Jul-18 18803162 31-Jan-19 18786297 31-Jan-19 18754879 31-Dec-18 18734778 30-Nov-18 18602423 30-Sep-18 18585290 31-Aug-18 18450430 30-Jun-18 18769816 31-Dec-18 18785485 31-Jan-19 18637274 31-Oct-18 18511110 31-Jul-18 18465901 30-Jun-18 18769700 31-Dec-18 18746995 31-Dec-18 18725103 30-Nov-18 18694228 30-Nov-18 18686012 30-Nov-18 18665561 31-Oct-18 18607752 30-Sep-18 18449575 30-Jun-18 18832355 28-Feb-19 18831744 31-Jan-19 18842138 28-Feb-19 18732878 30-Nov-18 18637216 31-Oct-18 18584252 31-Aug-18 18569882 31-Aug-18 18569766 31-Aug-18 18523410 31-Jul-18 19033487 30-Apr-19 18984845 30-Apr-19 18972140 30-Apr-19 18861952 28-Feb-19 18878607 28-Feb-19 19063170 31-May-19 18923191 31-Mar-19 18897527 28-Feb-19 18897185 28-Feb-19 18910290 31-Mar-19 19032199 30-Apr-19 19002213 30-Apr-19 19002155 30-Apr-19 18950942 31-Mar-19 18897698 28-Feb-19 18858983 28-Feb-19 19031329 30-Apr-19 19031909 30-Apr-19 19002271 30-Apr-19 18951058 31-Mar-19 18950884 31-Mar-19 18896843 28-Feb-19 18897014 28-Feb-19 18879010 28-Feb-19 18909942 31-Mar-19 18910638 31-Mar-19 18843872 28-Feb-19 19031619 30-Apr-19 19002329 30-Apr-19 18878204 28-Feb-19 18886556 28-Feb-19 18938172 31-Mar-19 18939594 31-Mar-19 18951000 31-Mar-19 18897356 28-Feb-19 18885142 28-Feb-19 18971589 30-Apr-19 18950826 31-Mar-19 18860449 28-Feb-19.
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 Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
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 Jun 6, 2016.
- FDA classified it on Jul 11, 2016.
- FDA’s Enforcement Report published it on Jul 20, 2016.
- FDA terminated it on Mar 3, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Neurovascular, of Fremont, CA.
- 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.”
- 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.