Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 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:M0035452060; Lot Number/Expiration Date: 18777380 31-Dec-18 18538894 31-Aug-18 18726354 30-Nov-18 18830541 31-Jan-19 18802659 31-Jan-19 18776332 31-Dec-18 18499021 31-Jul-18 18743910 30-Nov-18 18725944 30-Nov-18 18454649 30-Jun-18 18794568 31-Jan-19 18538832 31-Aug-18 18829512 31-Jan-19 18801344 31-Jan-19 18709049 30-Nov-18 18693095 30-Nov-18 18499207 31-Jul-18 19032899 30-Apr-19 19047487 31-May-19 18852469 28-Feb-19 18954631 31-Mar-19 18906669 28-Feb-19 18877336 28-Feb-19 19037939 31-May-19 18973118 30-Apr-19 18899998 28-Feb-19 18900840 28-Feb-19 19046456 31-May-19 18972772 30-Apr-19 18955537 31-Mar-19 19005724 30-Apr-19 18935230 31-Mar-19 18925282 31-Mar-19 18876468 28-Feb-19 19032992 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 HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 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:M0035452060; Lot Number/Expiration Date: 18777380 31-Dec-18 18538894 31-Aug-18 18726354 30-Nov-18 18830541 31-Jan-19 18802659 31-Jan-19 18776332 31-Dec-18 18499021 31-Jul-18 18743910 30-Nov-18 18725944 30-Nov-18 18454649 30-Jun-18 18794568 31-Jan-19 18538832 31-Aug-18 18829512 31-Jan-19 18801344 31-Jan-19 18709049 30-Nov-18 18693095 30-Nov-18 18499207 31-Jul-18 19032899 30-Apr-19 19047487 31-May-19 18852469 28-Feb-19 18954631 31-Mar-19 18906669 28-Feb-19 18877336 28-Feb-19 19037939 31-May-19 18973118 30-Apr-19 18899998 28-Feb-19 18900840 28-Feb-19 19046456 31-May-19 18972772 30-Apr-19 18955537 31-Mar-19 19005724 30-Apr-19 18935230 31-Mar-19 18925282 31-Mar-19 18876468 28-Feb-19 19032992 30-Apr-19.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2181-2016
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.