Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM
Medical device recall Z-2160-2016. 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 2 CM MODEL Number: M0035421020 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: M0035421020: Lot Number/Expiration Date: 18825272 31-Jan-19 18811666 31-Jan-19 18819711 31-Jan-19 18790659 31-Jan-19 18701550 30-Nov-18 18628881 31-Oct-18 18598937 30-Sep-18 18562915 31-Aug-18 18582507 30-Sep-18 18582275…
Every code shown here, 1,993 characters
MODEL Number: M0035421020: Lot Number/Expiration Date: 18825272 31-Jan-19 18811666 31-Jan-19 18819711 31-Jan-19 18790659 31-Jan-19 18701550 30-Nov-18 18628881 31-Oct-18 18598937 30-Sep-18 18562915 31-Aug-18 18582507 30-Sep-18 18582275 31-Aug-18 18819885 31-Jan-19 18811840 31-Jan-19 18742370 30-Nov-18 18714594 30-Nov-18 18723922 30-Nov-18 18701782 30-Nov-18 18701608 30-Nov-18 18677925 30-Nov-18 18657200 31-Oct-18 18667185 31-Oct-18 18667069 31-Oct-18 18647521 31-Oct-18 18599227 30-Sep-18 18582565 30-Sep-18 18553961 31-Aug-18 18790775 31-Jan-19 18790543 31-Jan-19 18742602 31-Dec-18 18647347 31-Oct-18 18604218 30-Sep-18 18585521 31-Aug-18 18515100 31-Jul-18 18825330 31-Jan-19 18790717 31-Jan-19 18723864 30-Nov-18 18742428 31-Dec-18 18714478 30-Nov-18 18729520 30-Nov-18 18677693 30-Nov-18 18657142 31-Oct-18 18638318 31-Oct-18 18647405 31-Oct-18 18604160 30-Sep-18 18825156 31-Jan-19 18825214 31-Jan-19 18819827 31-Jan-19 18811724 31-Jan-19 18729346 30-Nov-18 18701724 30-Nov-18 18657316 31-Oct-18 18623511 30-Nov-18 18647463 31-Oct-18 18599053 30-Sep-18 18591050 30-Sep-18 18534835 31-Aug-18 18819769 31-Jan-19 18811608 31-Jan-19 18825098 31-Jan-19 18759488 31-Dec-18 18701434 30-Nov-18 18667011 31-Oct-18 18628939 31-Oct-18 18598879 30-Sep-18 18591108 30-Sep-18 18562741 31-Aug-18 18534777 31-Aug-18 18790485 31-Jan-19 18701492 30-Nov-18 18666953 31-Oct-18 18638260 31-Oct-18 18598995 30-Sep-18 18599111 30-Sep-18 18554135 31-Aug-18 18515042 31-Jul-18 18469498 31-Jul-18 18447937 30-Jun-18 18811550 31-Jan-19 18790601 31-Jan-19 18677809 30-Nov-18 18591166 30-Sep-18 18590992 30-Sep-18 18582449 30-Sep-18 18582391 31-Aug-18 18582333 31-Aug-18 18554019 31-Aug-18 18515274 31-Jul-18 18488746 31-Jul-18 18965760 31-Mar-19 19030868 30-Apr-19 19030690 30-Apr-19 19044166 31-May-19 18977312 30-Apr-19 19071102 31-May-19 19013933 30-Apr-19 19071338 31-May-19 18977223 30-Apr-19 18946958 31-Mar-19 18896552 28-Feb-19 18916270 31-Mar-19 19082881 31-May-19 19030512 31-May-19 19030601 30-Apr-19…
FDA’s list runs to 2,962 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 2,962 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.