Hearth Record

Target Detachable Coils: TARGET 360 NANO 2MM X 4CM

Medical device recall Z-2173-2016. Published in FDA’s Enforcement Report on Jul 20, 2016.

FDA’s own record, on accessdata.fda.gov

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.

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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

MODEL Number: M0035442040: Lot Number/Expiration Date: 18824889 31-Jan-19 18789584 31-Jan-19 18715147 30-Nov-18 18654621 31-Oct-18 18583663 31-Aug-18 18779217 31-Dec-18 18771773 31-Dec-18 18758989 31-Dec-18 18715561 30-Nov-18 18567945…

Every code shown here, 1,993 characters

MODEL Number: M0035442040: Lot Number/Expiration Date: 18824889 31-Jan-19 18789584 31-Jan-19 18715147 30-Nov-18 18654621 31-Oct-18 18583663 31-Aug-18 18779217 31-Dec-18 18771773 31-Dec-18 18758989 31-Dec-18 18715561 30-Nov-18 18567945 31-Aug-18 18583694 30-Sep-18 18489927 31-Jul-18 18456251 30-Jun-18 18456101 30-Jun-18 18779279 31-Dec-18 18789344 31-Jan-19 18771711 31-Dec-18 18715383 30-Nov-18 18679151 30-Nov-18 18568131 31-Aug-18 18470407 30-Jun-18 18818239 31-Jan-19 18810301 31-Jan-19 18721156 30-Nov-18 18702459 30-Nov-18 18521395 31-Jul-18 18824769 31-Jan-19 18779248 31-Dec-18 18702490 30-Nov-18 18654590 31-Oct-18 18436562 30-Jun-18 18825009 31-Jan-19 18818208 31-Jan-19 18810061 31-Jan-19 18702552 30-Nov-18 18741929 30-Nov-18 18667537 31-Oct-18 18567883 31-Aug-18 18456191 30-Jun-18 18440768 30-Jun-18 18824649 31-Jan-19 18810181 31-Jan-19 18809941 31-Jan-19 18758869 31-Dec-18 18741991 30-Nov-18 18741898 30-Nov-18 18568007 31-Aug-18 18470287 30-Jun-18 18440708 30-Jun-18 18393710 31-May-18 18818177 31-Jan-19 18789464 31-Jan-19 18759109 31-Dec-18 18727865 30-Nov-18 18727745 30-Nov-18 18727625 30-Nov-18 18679089 30-Nov-18 18679120 30-Nov-18 18654528 31-Oct-18 18643778 31-Oct-18 18567914 31-Aug-18 18583725 30-Sep-18 18489834 31-Jul-18 19029955 30-Apr-19 19054722 31-May-19 19029924 30-Apr-19 19045373 31-May-19 19045249 31-May-19 19014943 30-Apr-19 18881427 28-Feb-19 18881017 28-Feb-19 18990009 30-Apr-19 19014850 30-Apr-19 18950447 31-Mar-19 18881632 28-Feb-19 18932694 31-Mar-19 18946218 31-Mar-19 19054784 31-May-19 19045404 31-May-19 19065216 31-May-19 18977548 30-Apr-19 18977459 30-Apr-19 18977370 30-Apr-19 18932725 31-Mar-19 19054660 31-May-19 19014757 30-Apr-19 18896432 28-Feb-19 18847681 31-Jan-19 19071276 31-May-19 19071040 31-May-19 19071512 31-May-19 19014881 30-Apr-19 19014819 30-Apr-19 18961269 31-Mar-19 18950385 31-Mar-19 19045342 31-May-19 18932663 31-Mar-19 18932632 31-Mar-19 18896699 28-Feb-19 18896610 28-Feb-19 18864702 28-Feb-19 18881222 28-Feb-19…

FDA’s list runs to 2,335 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 2,335 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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