🔍 RecallPedia

Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 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: M0035431020; Lot Number/Expiration Date: 18785369 31-Jan-19 18741318 30-Nov-18 18719333 30-Nov-18 18583254 30-Sep-18 18557530 31-Aug-18 18429528 30-Jun-18 18818792 31-Jan-19 18801607 31-Jan-19 18772009 31-Dec-18 18771835 31-Dec-18 18758722 31-Dec-18 18748395 31-Dec-18 18740448 30-Nov-18 18709718 30-Nov-18 18725975 30-Nov-18 18726385 30-Nov-18 18544137 31-Aug-18 18517433 31-Jul-18 18447952 30-Jun-18 18818618 31-Jan-19 18818444 31-Jan-19 18740738 30-Nov-18 18544079 31-Aug-18 18510936 31-Jul-18 18824386 31-Jan-19 18784557 31-Jan-19 18772067 31-Dec-18 18741608 31-Dec-18 18686476 30-Nov-18 18568905 31-Aug-18 18517549 31-Jul-18 18824444 28-Feb-19 18824502 31-Jan-19 18818270 31-Jan-19 18758107 31-Dec-18 18726180 30-Nov-18 18686650 30-Nov-18 18664543 31-Oct-18 18647231 31-Oct-18 18647173 31-Oct-18 18568963 31-Aug-18 18458590 30-Jun-18 18391277 31-May-18 18824328 31-Jan-19 18802922 31-Jan-19 18748105 31-Dec-18 18647115 31-Oct-18 18568847 31-Aug-18 18557472 31-Aug-18 18786181 31-Jan-19 18772183 31-Dec-18 18686534 30-Nov-18 18585000 31-Aug-18 18584194 31-Aug-18 18582103 30-Sep-18 18582045 30-Sep-18 18557356 31-Aug-18 18510878 31-Jul-18 18523236 31-Jul-18 18772125 31-Dec-18 18686418 30-Nov-18 18647289 31-Oct-18 18452822 30-Jun-18 18450373 30-Jun-18 19033545 30-Apr-19 19004591 30-Apr-19 19004475 30-Apr-19 19004417 30-Apr-19 18927253 31-Mar-19 18915458 31-Mar-19 18915748 31-Mar-19 18915574 31-Mar-19 18915516 31-Mar-19 18845790 28-Feb-19 19052916 31-May-19 18976256 30-Apr-19 18976844 30-Apr-19 18976550 30-Apr-19 18895388 28-Feb-19 18895098 28-Feb-19 19031967 30-Apr-19 18976403 30-Apr-19 19063228 31-May-19 18941012 31-Mar-19 18957807 31-Mar-19 18896258 28-Feb-19 18865965 28-Feb-19 18885463 28-Feb-19 18845411 28-Feb-19 18984961 30-Apr-19 19032257 30-Apr-19 19031387 30-Apr-19 18928771 31-Mar-19 18928012 31-Mar-19 18846169 31-Jan-19 18866197 28-Feb-19 18846548 28-Feb-19 19052595 31-May-19 18957227 31-Mar-19 18956647 31-Mar-19 18866658 28-Feb-19 18886877 28-Feb-19 19031677 30-Apr-19 19076325 31-May-19 18941476 31-Mar-19 18895678 31-Mar-19 18915690 31-Mar-19 18915632 31-Mar-19 18866890 28-Feb-19 18866429 28-Feb-19 19052274 31-May-19 19065800 31-May-19 19004533 30-Apr-19 19004359 30-Apr-19 18941940 31-Mar-19 19051953 31-May-19 18976697 30-Apr-19 18895968 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 2 CM MODEL Number:M0035431020 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: M0035431020; Lot Number/Expiration Date: 18785369 31-Jan-19 18741318 30-Nov-18 18719333 30-Nov-18 18583254 30-Sep-18 18557530 31-Aug-18 18429528 30-Jun-18 18818792 31-Jan-19 18801607 31-Jan-19 18772009 31-Dec-18 18771835 31-Dec-18 18758722 31-Dec-18 18748395 31-Dec-18 18740448 30-Nov-18 18709718 30-Nov-18 18725975 30-Nov-18 18726385 30-Nov-18 18544137 31-Aug-18 18517433 31-Jul-18 18447952 30-Jun-18 18818618 31-Jan-19 18818444 31-Jan-19 18740738 30-Nov-18 18544079 31-Aug-18 18510936 31-Jul-18 18824386 31-Jan-19 18784557 31-Jan-19 18772067 31-Dec-18 18741608 31-Dec-18 18686476 30-Nov-18 18568905 31-Aug-18 18517549 31-Jul-18 18824444 28-Feb-19 18824502 31-Jan-19 18818270 31-Jan-19 18758107 31-Dec-18 18726180 30-Nov-18 18686650 30-Nov-18 18664543 31-Oct-18 18647231 31-Oct-18 18647173 31-Oct-18 18568963 31-Aug-18 18458590 30-Jun-18 18391277 31-May-18 18824328 31-Jan-19 18802922 31-Jan-19 18748105 31-Dec-18 18647115 31-Oct-18 18568847 31-Aug-18 18557472 31-Aug-18 18786181 31-Jan-19 18772183 31-Dec-18 18686534 30-Nov-18 18585000 31-Aug-18 18584194 31-Aug-18 18582103 30-Sep-18 18582045 30-Sep-18 18557356 31-Aug-18 18510878 31-Jul-18 18523236 31-Jul-18 18772125 31-Dec-18 18686418 30-Nov-18 18647289 31-Oct-18 18452822 30-Jun-18 18450373 30-Jun-18 19033545 30-Apr-19 19004591 30-Apr-19 19004475 30-Apr-19 19004417 30-Apr-19 18927253 31-Mar-19 18915458 31-Mar-19 18915748 31-Mar-19 18915574 31-Mar-19 18915516 31-Mar-19 18845790 28-Feb-19 19052916 31-May-19 18976256 30-Apr-19 18976844 30-Apr-19 18976550 30-Apr-19 18895388 28-Feb-19 18895098 28-Feb-19 19031967 30-Apr-19 18976403 30-Apr-19 19063228 31-May-19 18941012 31-Mar-19 18957807 31-Mar-19 18896258 28-Feb-19 18865965 28-Feb-19 18885463 28-Feb-19 18845411 28-Feb-19 18984961 30-Apr-19 19032257 30-Apr-19 19031387 30-Apr-19 18928771 31-Mar-19 18928012 31-Mar-19 18846169 31-Jan-19 18866197 28-Feb-19 18846548 28-Feb-19 19052595 31-May-19 18957227 31-Mar-19 18956647 31-Mar-19 18866658 28-Feb-19 18886877 28-Feb-19 19031677 30-Apr-19 19076325 31-May-19 18941476 31-Mar-19 18895678 31-Mar-19 18915690 31-Mar-19 18915632 31-Mar-19 18866890 28-Feb-19 18866429 28-Feb-19 19052274 31-May-19 19065800 31-May-19 19004533 30-Apr-19 19004359 30-Apr-19 18941940 31-Mar-19 19051953 31-May-19 18976697 30-Apr-19 18895968 28-Feb-19.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2166-2016

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