Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM
Medical device recall Z-2163-2016. 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 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 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: M0035421530 Lot Number/Expiration Date: 18576579 31-Aug-18 18825794 31-Jan-19 18759372 31-Dec-18 18769642 31-Dec-18 18759430 31-Dec-18 18742312 30-Nov-18 18730158 30-Nov-18 18700332 30-Nov-18 18666315 31-Oct-18 18642494…
Every code shown here, 1,992 characters
MODEL Number: M0035421530 Lot Number/Expiration Date: 18576579 31-Aug-18 18825794 31-Jan-19 18759372 31-Dec-18 18769642 31-Dec-18 18759430 31-Dec-18 18742312 30-Nov-18 18730158 30-Nov-18 18700332 30-Nov-18 18666315 31-Oct-18 18642494 31-Oct-18 18598589 30-Sep-18 18598705 30-Sep-18 18590702 30-Sep-18 18571949 31-Aug-18 18576695 30-Sep-18 18542073 31-Aug-18 18553555 31-Aug-18 18461134 30-Jun-18 18487818 31-Jul-18 18482418 31-Jul-18 18455339 30-Jun-18 18790369 31-Jan-19 18790079 31-Jan-19 18759314 31-Dec-18 18700274 30-Nov-18 18700158 30-Nov-18 18676997 30-Nov-18 18676591 30-Nov-18 18642436 31-Oct-18 18620147 30-Sep-18 18633863 31-Oct-18 18473146 30-Jun-18 18482417 31-Jul-18 18473260 30-Jun-18 18433320 30-Jun-18 18419555 31-May-18 18406749 31-May-18 18398515 31-May-18 18811376 31-Jan-19 18825968 31-Jan-19 18816588 31-Jan-19 18790427 31-Jan-19 18790253 31-Jan-19 18700448 30-Nov-18 18629577 31-Oct-18 18660541 31-Oct-18 18642610 31-Oct-18 18590760 30-Sep-18 18571717 31-Aug-18 18455453 30-Jun-18 18811260 31-Jan-19 18811202 31-Jan-19 18811144 31-Jan-19 18790137 31-Jan-19 18769874 31-Dec-18 18769990 31-Dec-18 18742196 31-Dec-18 18742080 30-Nov-18 18598763 30-Sep-18 18590644 30-Sep-18 18571601 31-Aug-18 18524506 31-Jul-18 18433263 30-Jun-18 18817914 31-Jan-19 18811434 31-Jan-19 18660773 31-Oct-18 18642320 31-Oct-18 18642262 31-Oct-18 18553671 31-Aug-18 18811086 31-Jan-19 18714014 30-Nov-18 18676707 30-Nov-18 18666373 31-Oct-18 18666257 31-Oct-18 18620205 30-Sep-18 18619915 30-Sep-18 18461647 30-Jun-18 18433149 30-Jun-18 18826490 31-Jan-19 18826142 31-Jan-19 18825446 31-Jan-19 18817251 31-Jan-19 18790021 31-Jan-19 18776885 31-Dec-18 18742022 30-Nov-18 18730042 30-Nov-18 18676649 30-Nov-18 18660599 31-Oct-18 18619857 30-Sep-18 18629635 31-Oct-18 18590818 30-Sep-18 18571427 31-Aug-18 18541957 31-Aug-18 18391790 30-Apr-18 18398230 31-May-18 18826316 31-Jan-19 18825620 31-Jan-19 18811318 31-Jan-19 18714188 30-Nov-18 18700216 30-Nov-18 18676881 30-Nov-18 18660657 31-Oct-18…
FDA’s list runs to 3,816 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 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.”
- FDA’s list of codes runs to 3,816 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
-
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.