Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 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

What Should You Do?

  1. Check if you have this product:
    MODEL Number: M0035442540: Lot Number/Expiration Date: 18820098 31-Jan-19 18819974 31-Jan-19 18809411 31-Jan-19 18809117 31-Jan-19 18768594 31-Dec-18 18736394 30-Nov-18 18654342 31-Oct-18 18554516 31-Aug-18 18489245 31-Jul-18 18416403 31-May-18 18393530 30-Apr-18 18820005 31-Jan-19 18778602 31-Dec-18 18735178 30-Nov-18 18760121 31-Dec-18 18583787 30-Sep-18 18583880 30-Sep-18 18778397 31-Dec-18 18778807 31-Dec-18 18760123 31-Dec-18 18469927 31-Jul-18 18455711 30-Jun-18 18441368 30-Jun-18 18820036 31-Jan-19 18809705 31-Jan-19 18760120 31-Dec-18 18654156 31-Oct-18 18606693 30-Sep-18 18521064 31-Jul-18 18808823 31-Jan-19 18808529 31-Jan-19 18787828 31-Jan-19 18758428 31-Dec-18 18654187 31-Oct-18 18654280 31-Oct-18 18583942 30-Sep-18 18521126 31-Jul-18 18469957 31-Jul-18 18831210 31-Jan-19 18758018 31-Dec-18 18654125 31-Oct-18 18521095 31-Jul-18 18462388 30-Jun-18 18456041 30-Jun-18 18455861 30-Jun-18 18830181 31-Jan-19 18820067 31-Jan-19 18787623 31-Jan-19 18787213 31-Jan-19 18654249 31-Oct-18 18606631 30-Sep-18 18606600 30-Sep-18 18819943 31-Jan-19 18787418 31-Jan-19 18768273 31-Dec-18 18767952 31-Dec-18 18654373 31-Oct-18 18654311 31-Oct-18 18554485 31-Aug-18 18489183 31-Jul-18 18462418 30-Jun-18 18455921 30-Jun-18 18441488 30-Jun-18 18441458 30-Jun-18 18416223 31-May-18 19052974 31-May-19 19052653 31-May-19 19043872 31-May-19 19013488 30-Apr-19 19069385 31-May-19 18943892 31-Mar-19 18913849 28-Feb-19 19068743 31-May-19 18976461 30-Apr-19 18893796 28-Feb-19 18894175 28-Feb-19 18870346 28-Feb-19 18885258 28-Feb-19 18992380 30-Apr-19 19028025 30-Apr-19 19080185 31-May-19 19052011 31-May-19 18960332 31-Mar-19 18998928 30-Apr-19 19013666 30-Apr-19 18870085 28-Feb-19 18951913 31-Mar-19 18944415 31-Mar-19 18944938 31-Mar-19 18914375 31-Mar-19 18913323 28-Feb-19 19028265 30-Apr-19 19028145 30-Apr-19 19043694 31-May-19 19069064 31-May-19 19013844 30-Apr-19 18951441 31-Mar-19 18929003 31-Mar-19 18913586 28-Feb-19 18870284 28-Feb-19 18870025 28-Feb-19 18992349 30-Apr-19 19027905 30-Apr-19 19043605 31-May-19 19043961 31-May-19 19068422 31-May-19 18999021 30-Apr-19 18998990 30-Apr-19 18976755 30-Apr-19 18976608 30-Apr-19 18893417 28-Feb-19 18943369 31-Mar-19 18992566 30-Apr-19 19052332 31-May-19 18976902 30-Apr-19 18951205 31-Mar-19 18894554 28-Feb-19 18905687 28-Feb-19 18886672 28-Feb-19 18875678 28-Feb-19 19080007 31-May-19 19013399 30-Apr-19 19013755 30-Apr-19 19013577 30-Apr-19 18952385 31-Mar-19 18905718 28-Feb-19 18914112 31-Mar-19 18870222 28-Feb-19 19043783 31-May-19 18927485 31-Mar-19 18952149 31-Mar-19 18951677 31-Mar-19 18928244 31-Mar-19 18870425 28-Feb-19 18870160 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 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 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: M0035442540: Lot Number/Expiration Date: 18820098 31-Jan-19 18819974 31-Jan-19 18809411 31-Jan-19 18809117 31-Jan-19 18768594 31-Dec-18 18736394 30-Nov-18 18654342 31-Oct-18 18554516 31-Aug-18 18489245 31-Jul-18 18416403 31-May-18 18393530 30-Apr-18 18820005 31-Jan-19 18778602 31-Dec-18 18735178 30-Nov-18 18760121 31-Dec-18 18583787 30-Sep-18 18583880 30-Sep-18 18778397 31-Dec-18 18778807 31-Dec-18 18760123 31-Dec-18 18469927 31-Jul-18 18455711 30-Jun-18 18441368 30-Jun-18 18820036 31-Jan-19 18809705 31-Jan-19 18760120 31-Dec-18 18654156 31-Oct-18 18606693 30-Sep-18 18521064 31-Jul-18 18808823 31-Jan-19 18808529 31-Jan-19 18787828 31-Jan-19 18758428 31-Dec-18 18654187 31-Oct-18 18654280 31-Oct-18 18583942 30-Sep-18 18521126 31-Jul-18 18469957 31-Jul-18 18831210 31-Jan-19 18758018 31-Dec-18 18654125 31-Oct-18 18521095 31-Jul-18 18462388 30-Jun-18 18456041 30-Jun-18 18455861 30-Jun-18 18830181 31-Jan-19 18820067 31-Jan-19 18787623 31-Jan-19 18787213 31-Jan-19 18654249 31-Oct-18 18606631 30-Sep-18 18606600 30-Sep-18 18819943 31-Jan-19 18787418 31-Jan-19 18768273 31-Dec-18 18767952 31-Dec-18 18654373 31-Oct-18 18654311 31-Oct-18 18554485 31-Aug-18 18489183 31-Jul-18 18462418 30-Jun-18 18455921 30-Jun-18 18441488 30-Jun-18 18441458 30-Jun-18 18416223 31-May-18 19052974 31-May-19 19052653 31-May-19 19043872 31-May-19 19013488 30-Apr-19 19069385 31-May-19 18943892 31-Mar-19 18913849 28-Feb-19 19068743 31-May-19 18976461 30-Apr-19 18893796 28-Feb-19 18894175 28-Feb-19 18870346 28-Feb-19 18885258 28-Feb-19 18992380 30-Apr-19 19028025 30-Apr-19 19080185 31-May-19 19052011 31-May-19 18960332 31-Mar-19 18998928 30-Apr-19 19013666 30-Apr-19 18870085 28-Feb-19 18951913 31-Mar-19 18944415 31-Mar-19 18944938 31-Mar-19 18914375 31-Mar-19 18913323 28-Feb-19 19028265 30-Apr-19 19028145 30-Apr-19 19043694 31-May-19 19069064 31-May-19 19013844 30-Apr-19 18951441 31-Mar-19 18929003 31-Mar-19 18913586 28-Feb-19 18870284 28-Feb-19 18870025 28-Feb-19 18992349 30-Apr-19 19027905 30-Apr-19 19043605 31-May-19 19043961 31-May-19 19068422 31-May-19 18999021 30-Apr-19 18998990 30-Apr-19 18976755 30-Apr-19 18976608 30-Apr-19 18893417 28-Feb-19 18943369 31-Mar-19 18992566 30-Apr-19 19052332 31-May-19 18976902 30-Apr-19 18951205 31-Mar-19 18894554 28-Feb-19 18905687 28-Feb-19 18886672 28-Feb-19 18875678 28-Feb-19 19080007 31-May-19 19013399 30-Apr-19 19013755 30-Apr-19 19013577 30-Apr-19 18952385 31-Mar-19 18905718 28-Feb-19 18914112 31-Mar-19 18870222 28-Feb-19 19043783 31-May-19 18927485 31-Mar-19 18952149 31-Mar-19 18951677 31-Mar-19 18928244 31-Mar-19 18870425 28-Feb-19 18870160 28-Feb-19.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2174-2016

Related Recalls

Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.

Aug 30, 2024 Surgical Instruments Nationwide View Details →

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

Apr 18, 2024 Diagnostic Equipment Nationwide View Details →

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

Apr 18, 2024 Diagnostic Equipment Nationwide View Details →