Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Class I - DangerousWhat Should You Do?
- Check if you have this product: MODEL Number: M0035421030: Lot Number/Expiration Date: 18604566 30-Sep-18 18488920 31-Jul-18 18807744 31-Jan-19 18807570 31-Jan-19 18677403 31-Oct-18 18666895 31-Oct-18 18654009 31-Oct-18 18647637 31-Oct-18 18629287 31-Oct-18 18542421 31-Aug-18 18554251 31-Aug-18 18469669 30-Jun-18 18462274 30-Jun-18 18462217 30-Jun-18 18393386 30-Apr-18 18814099 31-Jan-19 18788265 31-Jan-19 18769352 31-Dec-18 18714536 30-Nov-18 18701840 30-Nov-18 18677577 30-Nov-18 18677461 30-Nov-18 18629171 31-Oct-18 18604508 30-Sep-18 18582681 30-Sep-18 18535009 31-Aug-18 18426357 30-Jun-18 18714768 30-Nov-18 18714652 30-Nov-18 18629229 31-Oct-18 18554193 31-Aug-18 18701898 30-Nov-18 18730274 30-Nov-18 18677519 30-Nov-18 18653835 31-Oct-18 18831481 31-Jan-19 18769468 31-Dec-18 18714304 30-Nov-18 18807918 31-Jan-19 18714420 30-Nov-18 18654067 31-Oct-18 18638376 31-Oct-18 18590876 30-Sep-18 18604450 30-Sep-18 18488978 31-Jul-18 18469612 30-Jun-18 18831539 31-Jan-19 18788439 31-Jan-19 18736862 31-Dec-18 18736746 30-Nov-18 18666837 31-Oct-18 18666779 31-Oct-18 18653893 31-Oct-18 18604392 30-Sep-18 18542479 31-Aug-18 18931539 31-Mar-19 18901428 28-Feb-19 19048197 31-May-19 18945290 31-Mar-19 18931771 31-Mar-19 18846927 31-Jan-19 18909826 31-Mar-19 18887689 28-Feb-19 18887573 28-Feb-19 18847159 28-Feb-19 18976078 30-Apr-19 19025545 30-Apr-19 19043431 31-May-19 18975900 30-Apr-19 18975989 30-Apr-19 19067208 31-May-19 18954139 31-Mar-19 18961180 31-Mar-19 18961060 31-Mar-19 18945174 31-Mar-19 18931307 31-Mar-19 18847043 31-Jan-19 19025429 30-Apr-19 19048139 31-May-19 18945406 31-Mar-19 18901486 28-Feb-19 18909768 28-Feb-19 19043373 31-May-19 19012218 30-Apr-19 19012392 30-Apr-19 18976167 30-Apr-19 18854389 28-Feb-19 19012044 30-Apr-19.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 1 MM X 3 CM MODEL Number: M0035421030 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: M0035421030: Lot Number/Expiration Date: 18604566 30-Sep-18 18488920 31-Jul-18 18807744 31-Jan-19 18807570 31-Jan-19 18677403 31-Oct-18 18666895 31-Oct-18 18654009 31-Oct-18 18647637 31-Oct-18 18629287 31-Oct-18 18542421 31-Aug-18 18554251 31-Aug-18 18469669 30-Jun-18 18462274 30-Jun-18 18462217 30-Jun-18 18393386 30-Apr-18 18814099 31-Jan-19 18788265 31-Jan-19 18769352 31-Dec-18 18714536 30-Nov-18 18701840 30-Nov-18 18677577 30-Nov-18 18677461 30-Nov-18 18629171 31-Oct-18 18604508 30-Sep-18 18582681 30-Sep-18 18535009 31-Aug-18 18426357 30-Jun-18 18714768 30-Nov-18 18714652 30-Nov-18 18629229 31-Oct-18 18554193 31-Aug-18 18701898 30-Nov-18 18730274 30-Nov-18 18677519 30-Nov-18 18653835 31-Oct-18 18831481 31-Jan-19 18769468 31-Dec-18 18714304 30-Nov-18 18807918 31-Jan-19 18714420 30-Nov-18 18654067 31-Oct-18 18638376 31-Oct-18 18590876 30-Sep-18 18604450 30-Sep-18 18488978 31-Jul-18 18469612 30-Jun-18 18831539 31-Jan-19 18788439 31-Jan-19 18736862 31-Dec-18 18736746 30-Nov-18 18666837 31-Oct-18 18666779 31-Oct-18 18653893 31-Oct-18 18604392 30-Sep-18 18542479 31-Aug-18 18931539 31-Mar-19 18901428 28-Feb-19 19048197 31-May-19 18945290 31-Mar-19 18931771 31-Mar-19 18846927 31-Jan-19 18909826 31-Mar-19 18887689 28-Feb-19 18887573 28-Feb-19 18847159 28-Feb-19 18976078 30-Apr-19 19025545 30-Apr-19 19043431 31-May-19 18975900 30-Apr-19 18975989 30-Apr-19 19067208 31-May-19 18954139 31-Mar-19 18961180 31-Mar-19 18961060 31-Mar-19 18945174 31-Mar-19 18931307 31-Mar-19 18847043 31-Jan-19 19025429 30-Apr-19 19048139 31-May-19 18945406 31-Mar-19 18901486 28-Feb-19 18909768 28-Feb-19 19043373 31-May-19 19012218 30-Apr-19 19012392 30-Apr-19 18976167 30-Apr-19 18854389 28-Feb-19 19012044 30-Apr-19.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2161-2016
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.
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.
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.