Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 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:M0035443040 : Lot Number/Expiration Date: 18442838 30-Jun-18 18442388 30-Jun-18 18490600 31-Jul-18 18831276 31-Jan-19 18760116 31-Dec-18 18760119 31-Dec-18 18584035 30-Sep-18 18470827 31-Jul-18 18442358 30-Jun-18 18830247 31-Jan-19 18470767 30-Jun-18 18470857 31-Jul-18 18800019 31-Jan-19 18760117 31-Dec-18 18568317 31-Aug-18 18462748 30-Jun-18 18443108 30-Jun-18 18442178 30-Jun-18 18568224 31-Aug-18 18490538 31-Jul-18 18462838 30-Jun-18 18568193 31-Aug-18 18584004 30-Sep-18 18490662 31-Jul-18 18442688 30-Jun-18 19066241 31-May-19 19035290 31-May-19 18902944 28-Feb-19 18877825 28-Feb-19 18973721 30-Apr-19 18846664 31-Jan-19 19081717 31-May-19 19026562 30-Apr-19 18973029 30-Apr-19 18876957 28-Feb-19 18905865 28-Feb-19 19027086 30-Apr-19 19080897 31-May-19 19063669 31-May-19 18845906 31-Jan-19 18845527 31-Jan-19 19026038 30-Apr-19 18902302 28-Feb-19 18846285 31-Jan-19 19081102 31-May-19 18901660 28-Feb-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 3MM X 4CM MODEL Number:M0035443040 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:M0035443040 : Lot Number/Expiration Date: 18442838 30-Jun-18 18442388 30-Jun-18 18490600 31-Jul-18 18831276 31-Jan-19 18760116 31-Dec-18 18760119 31-Dec-18 18584035 30-Sep-18 18470827 31-Jul-18 18442358 30-Jun-18 18830247 31-Jan-19 18470767 30-Jun-18 18470857 31-Jul-18 18800019 31-Jan-19 18760117 31-Dec-18 18568317 31-Aug-18 18462748 30-Jun-18 18443108 30-Jun-18 18442178 30-Jun-18 18568224 31-Aug-18 18490538 31-Jul-18 18462838 30-Jun-18 18568193 31-Aug-18 18584004 30-Sep-18 18490662 31-Jul-18 18442688 30-Jun-18 19066241 31-May-19 19035290 31-May-19 18902944 28-Feb-19 18877825 28-Feb-19 18973721 30-Apr-19 18846664 31-Jan-19 19081717 31-May-19 19026562 30-Apr-19 18973029 30-Apr-19 18876957 28-Feb-19 18905865 28-Feb-19 19027086 30-Apr-19 19080897 31-May-19 19063669 31-May-19 18845906 31-Jan-19 18845527 31-Jan-19 19026038 30-Apr-19 18902302 28-Feb-19 18846285 31-Jan-19 19081102 31-May-19 18901660 28-Feb-19.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2175-2016
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.