🔍 RecallPedia

Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Class I - Dangerous
🏥 Medical Devices Recalled: June 6, 2016 Stryker Neurovascular Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    MODEL Number: M0035431010 Lot Number/Expiration Date: 18784731 31-Jan-19 18767279 31-Dec-18 18685490 30-Nov-18 18592036 30-Sep-18 18818328 31-Jan-19 18723284 30-Nov-18 18630215 31-Oct-18 18601959 30-Sep-18 18414374 31-May-18 18748453 31-Dec-18 18730570 30-Nov-18 18606940 30-Sep-18 18403443 31-May-18 18818502 31-Jan-19 18796245 31-Jan-19 18627513 31-Oct-18 18601901 30-Sep-18 18581353 30-Sep-18 18484777 31-Jul-18 18818676 31-Jan-19 18777759 31-Dec-18 18484661 31-Jul-18 18429414 30-Jun-18 18801963 31-Jan-19 18803278 31-Jan-19 18786355 31-Jan-19 18776711 31-Dec-18 18767778 31-Dec-18 18723052 30-Nov-18 18539797 31-Aug-18 18417674 31-May-18 18831860 31-Jan-19 18818850 31-Jan-19 18739085 30-Nov-18 18833082 31-Jan-19 18748163 31-Dec-18 18738163 30-Nov-18 18602017 30-Sep-18 18581469 31-Aug-18 18543905 31-Aug-18 18450658 30-Jun-18 19002735 30-Apr-19 18941882 31-Mar-19 18941418 31-Mar-19 18930269 31-Mar-19 18894264 28-Feb-19 18893885 28-Feb-19 18885637 28-Feb-19 18957343 31-Mar-19 18956763 31-Mar-19 18940954 31-Mar-19 18857373 28-Feb-19 18975521 30-Apr-19 18975084 30-Apr-19 18847507 28-Feb-19 18930614 31-Mar-19 18847275 31-Jan-19 19002909 30-Apr-19 18929924 31-Mar-19 18847333 31-Jan-19 19062880 31-May-19 19002851 30-Apr-19 19002677 30-Apr-19 18974210 30-Apr-19 18930959 31-Mar-19 18906932 31-Mar-19 19046992 31-May-19 19002793 30-Apr-19 18893506 28-Feb-19 18887051 28-Feb-19 18847391 28-Feb-19 18984787 30-Apr-19 19037618 31-May-19 19064752 31-May-19 18894643 28-Feb-19.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Stryker Neurovascular
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Product Codes/Lot Numbers:

MODEL Number: M0035431010 Lot Number/Expiration Date: 18784731 31-Jan-19 18767279 31-Dec-18 18685490 30-Nov-18 18592036 30-Sep-18 18818328 31-Jan-19 18723284 30-Nov-18 18630215 31-Oct-18 18601959 30-Sep-18 18414374 31-May-18 18748453 31-Dec-18 18730570 30-Nov-18 18606940 30-Sep-18 18403443 31-May-18 18818502 31-Jan-19 18796245 31-Jan-19 18627513 31-Oct-18 18601901 30-Sep-18 18581353 30-Sep-18 18484777 31-Jul-18 18818676 31-Jan-19 18777759 31-Dec-18 18484661 31-Jul-18 18429414 30-Jun-18 18801963 31-Jan-19 18803278 31-Jan-19 18786355 31-Jan-19 18776711 31-Dec-18 18767778 31-Dec-18 18723052 30-Nov-18 18539797 31-Aug-18 18417674 31-May-18 18831860 31-Jan-19 18818850 31-Jan-19 18739085 30-Nov-18 18833082 31-Jan-19 18748163 31-Dec-18 18738163 30-Nov-18 18602017 30-Sep-18 18581469 31-Aug-18 18543905 31-Aug-18 18450658 30-Jun-18 19002735 30-Apr-19 18941882 31-Mar-19 18941418 31-Mar-19 18930269 31-Mar-19 18894264 28-Feb-19 18893885 28-Feb-19 18885637 28-Feb-19 18957343 31-Mar-19 18956763 31-Mar-19 18940954 31-Mar-19 18857373 28-Feb-19 18975521 30-Apr-19 18975084 30-Apr-19 18847507 28-Feb-19 18930614 31-Mar-19 18847275 31-Jan-19 19002909 30-Apr-19 18929924 31-Mar-19 18847333 31-Jan-19 19062880 31-May-19 19002851 30-Apr-19 19002677 30-Apr-19 18974210 30-Apr-19 18930959 31-Mar-19 18906932 31-Mar-19 19046992 31-May-19 19002793 30-Apr-19 18893506 28-Feb-19 18887051 28-Feb-19 18847391 28-Feb-19 18984787 30-Apr-19 19037618 31-May-19 19064752 31-May-19 18894643 28-Feb-19.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2165-2016

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