Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM
Medical device recall Z-2162-2016. 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 2 CM MODEL Number: M0035421520 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: M0035421520: Lot Number/Expiration Date: 18571775 31-Aug-18 18826432 31-Jan-19 18820709 31-Jan-19 18810506 31-Jan-19 18771506 31-Dec-18 18742834 31-Dec-18 18641914 31-Oct-18 18660947 31-Oct-18 18432978 30-Jun-18 18825388…
Every code shown here, 1,993 characters
MODEL Number: M0035421520: Lot Number/Expiration Date: 18571775 31-Aug-18 18826432 31-Jan-19 18820709 31-Jan-19 18810506 31-Jan-19 18771506 31-Dec-18 18742834 31-Dec-18 18641914 31-Oct-18 18660947 31-Oct-18 18432978 30-Jun-18 18825388 31-Jan-19 18810970 31-Jan-19 18820593 31-Jan-19 18758780 31-Dec-18 18789731 31-Jan-19 18742776 31-Dec-18 18721938 30-Nov-18 18676533 30-Nov-18 18633805 31-Oct-18 18641972 31-Oct-18 18825910 31-Jan-19 18826258 31-Jan-19 18701086 30-Nov-18 18742718 31-Dec-18 18676359 30-Nov-18 18700796 30-Nov-18 18666663 31-Oct-18 18625251 31-Oct-18 18642030 31-Oct-18 18598415 30-Sep-18 18534255 31-Aug-18 18821173 28-Feb-19 18810390 31-Jan-19 18789847 31-Jan-19 18789673 31-Jan-19 18758370 31-Dec-18 18728186 30-Nov-18 18700680 30-Nov-18 18625135 30-Sep-18 18576927 30-Sep-18 18534545 31-Aug-18 18487470 31-Jul-18 18460621 30-Jun-18 18826084 31-Jan-19 18825736 31-Jan-19 18825562 31-Jan-19 18810738 31-Jan-19 18820941 31-Jan-19 18820825 31-Jan-19 18778633 31-Dec-18 18742950 31-Dec-18 18714130 30-Nov-18 18666489 31-Oct-18 18625193 30-Sep-18 18629461 31-Oct-18 18590180 30-Sep-18 18562973 31-Aug-18 18534023 31-Aug-18 18563089 31-Aug-18 18406635 31-May-18 18642088 31-Oct-18 18810622 31-Jan-19 18778428 31-Dec-18 18789963 31-Jan-19 18771622 31-Dec-18 18722727 30-Nov-18 18701028 30-Nov-18 18648913 31-Oct-18 18666547 31-Oct-18 18590354 30-Sep-18 18563263 31-Aug-18 18821057 31-Jan-19 18771042 31-Dec-18 18742660 31-Dec-18 18700970 30-Nov-18 18660831 31-Oct-18 18563321 31-Aug-18 18582739 30-Sep-18 18559308 31-Aug-18 18482415 30-Jun-18 18439457 30-Jun-18 18789905 31-Jan-19 18810854 31-Jan-19 18820477 31-Jan-19 18789789 31-Jan-19 18758575 31-Dec-18 18742892 30-Nov-18 18700912 30-Nov-18 18700622 30-Nov-18 18660889 31-Oct-18 18642146 31-Oct-18 18641856 31-Oct-18 18563147 31-Aug-18 18439343 30-Jun-18 18397945 31-May-18 19055171 31-May-19 19028965 30-Apr-19 19028733 30-Apr-19 18991622 30-Apr-19 19070054 31-May-19 19069822 31-May-19 19014397 30-Apr-19 18948006 31-Mar-19…
FDA’s list runs to 3,589 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 3,589 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
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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.