Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM
Medical device recall Z-2161-2016. 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 MM X 3 CM MODEL Number: M0035421030 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: M0035421030: Lot Number/Expiration Date: 18604566 30-Sep-18 18488920 31-Jul-18 18807744 31-Jan-19 18807570 31-Jan-19 18677403 31-Oct-18 18666895 31-Oct-18 18654009 31-Oct-18 18647637 31-Oct-18 18629287 31-Oct-18 18542421…
Every code shown here, 1,727 characters
MODEL Number: M0035421030: Lot Number/Expiration Date: 18604566 30-Sep-18 18488920 31-Jul-18 18807744 31-Jan-19 18807570 31-Jan-19 18677403 31-Oct-18 18666895 31-Oct-18 18654009 31-Oct-18 18647637 31-Oct-18 18629287 31-Oct-18 18542421 31-Aug-18 18554251 31-Aug-18 18469669 30-Jun-18 18462274 30-Jun-18 18462217 30-Jun-18 18393386 30-Apr-18 18814099 31-Jan-19 18788265 31-Jan-19 18769352 31-Dec-18 18714536 30-Nov-18 18701840 30-Nov-18 18677577 30-Nov-18 18677461 30-Nov-18 18629171 31-Oct-18 18604508 30-Sep-18 18582681 30-Sep-18 18535009 31-Aug-18 18426357 30-Jun-18 18714768 30-Nov-18 18714652 30-Nov-18 18629229 31-Oct-18 18554193 31-Aug-18 18701898 30-Nov-18 18730274 30-Nov-18 18677519 30-Nov-18 18653835 31-Oct-18 18831481 31-Jan-19 18769468 31-Dec-18 18714304 30-Nov-18 18807918 31-Jan-19 18714420 30-Nov-18 18654067 31-Oct-18 18638376 31-Oct-18 18590876 30-Sep-18 18604450 30-Sep-18 18488978 31-Jul-18 18469612 30-Jun-18 18831539 31-Jan-19 18788439 31-Jan-19 18736862 31-Dec-18 18736746 30-Nov-18 18666837 31-Oct-18 18666779 31-Oct-18 18653893 31-Oct-18 18604392 30-Sep-18 18542479 31-Aug-18 18931539 31-Mar-19 18901428 28-Feb-19 19048197 31-May-19 18945290 31-Mar-19 18931771 31-Mar-19 18846927 31-Jan-19 18909826 31-Mar-19 18887689 28-Feb-19 18887573 28-Feb-19 18847159 28-Feb-19 18976078 30-Apr-19 19025545 30-Apr-19 19043431 31-May-19 18975900 30-Apr-19 18975989 30-Apr-19 19067208 31-May-19 18954139 31-Mar-19 18961180 31-Mar-19 18961060 31-Mar-19 18945174 31-Mar-19 18931307 31-Mar-19 18847043 31-Jan-19 19025429 30-Apr-19 19048139 31-May-19 18945406 31-Mar-19 18901486 28-Feb-19 18909768 28-Feb-19 19043373 31-May-19 19012218 30-Apr-19 19012392 30-Apr-19 18976167 30-Apr-19 18854389 28-Feb-19 19012044 30-Apr-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.