🔍 RecallPedia

Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 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: M0035431530: Lot Number/Expiration Date: 18758254 31-Dec-18 18685258 30-Nov-18 18651285 31-Oct-18 18637564 31-Oct-18 18426876 31-May-18 18802748 31-Jan-19 18758459 31-Dec-18 18709486 30-Nov-18 18637506 31-Oct-18 18551662 31-Aug-18 18551894 31-Aug-18 18551778 31-Aug-18 18503529 31-Jul-18 18466471 30-Jun-18 18841964 31-Jan-19 18829601 31-Jan-19 18758049 31-Dec-18 18767569 31-Dec-18 18685548 30-Nov-18 18651227 31-Oct-18 18551604 31-Aug-18 18830630 31-Jan-19 18843698 28-Feb-19 18842831 31-Jan-19 18637390 31-Oct-18 18592500 30-Sep-18 18557240 31-Aug-18 18627281 31-Oct-18 18776363 31-Dec-18 18767070 31-Dec-18 18732530 30-Nov-18 18551836 31-Aug-18 18453506 30-Jun-18 18815140 31-Jan-19 18814270 31-Jan-19 18780961 31-Jan-19 18766571 31-Dec-18 18637448 31-Oct-18 18522949 31-Jul-18 18518477 31-Jul-18 18801433 31-Jan-19 18777411 31-Dec-18 18735646 31-Dec-18 18734430 30-Nov-18 18685838 31-Oct-18 18722263 30-Nov-18 18458818 30-Jun-18 18402198 31-May-18 19049471 31-May-19 19005345 30-Apr-19 18975463 30-Apr-19 18895272 28-Feb-19 18985193 30-Apr-19 19005403 30-Apr-19 19060071 31-May-19 18974589 30-Apr-19 18944128 31-Mar-19 18943082 31-Mar-19 19032025 30-Apr-19 18950234 31-Mar-19 18862184 28-Feb-19 18860682 28-Feb-19 18877220 28-Feb-19 19031155 30-Apr-19 18949886 31-Mar-19 18949712 31-Mar-19 18896142 28-Feb-19 18895852 28-Feb-19 18859219 28-Feb-19 18889081 28-Feb-19 19031445 30-Apr-19 18928887 31-Mar-19 18928128 31-Mar-19 19005287 30-Apr-19 18974152 30-Apr-19 18950060 31-Mar-19 18944651 31-Mar-19 18888559 28-Feb-19 19031735 30-Apr-19 19050513 31-May-19 18975026 30-Apr-19 18888037 28-Feb-19 18943605 31-Mar-19 18927369 31-Mar-19 18894982 28-Feb-19 18876352 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 1.5 MM X 3 CM MODEL Number:M0035431530 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: M0035431530: Lot Number/Expiration Date: 18758254 31-Dec-18 18685258 30-Nov-18 18651285 31-Oct-18 18637564 31-Oct-18 18426876 31-May-18 18802748 31-Jan-19 18758459 31-Dec-18 18709486 30-Nov-18 18637506 31-Oct-18 18551662 31-Aug-18 18551894 31-Aug-18 18551778 31-Aug-18 18503529 31-Jul-18 18466471 30-Jun-18 18841964 31-Jan-19 18829601 31-Jan-19 18758049 31-Dec-18 18767569 31-Dec-18 18685548 30-Nov-18 18651227 31-Oct-18 18551604 31-Aug-18 18830630 31-Jan-19 18843698 28-Feb-19 18842831 31-Jan-19 18637390 31-Oct-18 18592500 30-Sep-18 18557240 31-Aug-18 18627281 31-Oct-18 18776363 31-Dec-18 18767070 31-Dec-18 18732530 30-Nov-18 18551836 31-Aug-18 18453506 30-Jun-18 18815140 31-Jan-19 18814270 31-Jan-19 18780961 31-Jan-19 18766571 31-Dec-18 18637448 31-Oct-18 18522949 31-Jul-18 18518477 31-Jul-18 18801433 31-Jan-19 18777411 31-Dec-18 18735646 31-Dec-18 18734430 30-Nov-18 18685838 31-Oct-18 18722263 30-Nov-18 18458818 30-Jun-18 18402198 31-May-18 19049471 31-May-19 19005345 30-Apr-19 18975463 30-Apr-19 18895272 28-Feb-19 18985193 30-Apr-19 19005403 30-Apr-19 19060071 31-May-19 18974589 30-Apr-19 18944128 31-Mar-19 18943082 31-Mar-19 19032025 30-Apr-19 18950234 31-Mar-19 18862184 28-Feb-19 18860682 28-Feb-19 18877220 28-Feb-19 19031155 30-Apr-19 18949886 31-Mar-19 18949712 31-Mar-19 18896142 28-Feb-19 18895852 28-Feb-19 18859219 28-Feb-19 18889081 28-Feb-19 19031445 30-Apr-19 18928887 31-Mar-19 18928128 31-Mar-19 19005287 30-Apr-19 18974152 30-Apr-19 18950060 31-Mar-19 18944651 31-Mar-19 18888559 28-Feb-19 19031735 30-Apr-19 19050513 31-May-19 18975026 30-Apr-19 18888037 28-Feb-19 18943605 31-Mar-19 18927369 31-Mar-19 18894982 28-Feb-19 18876352 28-Feb-19.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2170-2016

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