Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM
Medical device recall Z-2167-2016. 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 MM X 3 CM MODEL Number:M0035431030 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: M0035431030; Lot Number/Expiration Date: 18801491 31-Jan-19 18757273 31-Dec-18 18709428 30-Nov-18 18602133 30-Sep-18 18523870 31-Jul-18 18802806 31-Jan-19 18664601 31-Oct-18 18569137 31-Aug-18 18517839 31-Jul-18 18486090…
Every code shown here, 1,309 characters
MODEL Number: M0035431030; Lot Number/Expiration Date: 18801491 31-Jan-19 18757273 31-Dec-18 18709428 30-Nov-18 18602133 30-Sep-18 18523870 31-Jul-18 18802806 31-Jan-19 18664601 31-Oct-18 18569137 31-Aug-18 18517839 31-Jul-18 18486090 31-Jul-18 18842022 31-Jan-19 18651923 31-Oct-18 18651865 31-Oct-18 18607288 30-Sep-18 18518071 31-Jul-18 18774611 31-Dec-18 18762227 31-Dec-18 18637042 31-Oct-18 18564861 31-Aug-18 18843756 28-Feb-19 18842889 31-Jan-19 18781019 31-Jan-19 18651981 31-Oct-18 18546861 31-Aug-18 18447942 30-Jun-18 18830688 31-Jan-19 18815198 31-Jan-19 18814328 31-Jan-19 18736978 30-Nov-18 18592210 30-Sep-18 18517955 31-Jul-18 18414488 31-May-18 18829659 31-Jan-19 18583312 31-Aug-18 18984903 30-Apr-19 19050397 31-May-19 18883354 28-Feb-19 18911821 31-Mar-19 19041285 30-Apr-19 18944244 31-Mar-19 18922785 31-Mar-19 18902333 28-Feb-19 18911418 31-Mar-19 18857263 28-Feb-19 18973207 30-Apr-19 19041807 30-Apr-19 19065916 31-May-19 19063344 31-May-19 18901691 28-Feb-19 19074243 31-May-19 19049355 31-May-19 19042329 31-May-19 19005113 30-Apr-19 18944767 31-Mar-19 18973553 30-Apr-19 18943198 31-Mar-19 18943721 31-Mar-19 19042851 31-May-19 18855184 28-Feb-19 19048313 31-May-19 18972861 30-Apr-19 18953849 31-Mar-19 18912224 31-Mar-19 19005171 30-Apr-19 18902975 28-Feb-19 18912627 31-Mar-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.