Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 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: M0035431540: Lot Number/Expiration Date: 18843121 28-Feb-19 18842254 28-Feb-19 18752256 31-Dec-18 18637622 31-Oct-18 18531974 31-Aug-18 18450202 30-Jun-18 18765704 31-Dec-18 18749439 31-Dec-18 18748627 31-Dec-18 18546175 31-Aug-18 18546117 31-Aug-18 18556378 31-Aug-18 18538344 31-Aug-18 18749033 31-Dec-18 18602307 30-Sep-18 18532032 31-Jul-18 18802864 31-Jan-19 18797083 31-Jan-19 18794216 31-Jan-19 18812672 31-Jan-19 18637738 31-Oct-18 18607230 31-Oct-18 18637680 31-Oct-18 18449404 30-Jun-18 18794100 31-Jan-19 18776421 31-Dec-18 18602365 30-Sep-18 18581643 30-Sep-18 18801549 31-Jan-19 18737036 31-Dec-18 18602249 30-Sep-18 18486380 31-Jul-18 18486322 31-Jul-18 19086644 31-May-19 18941592 31-Mar-19 19086586 31-May-19 18973495 30-Apr-19 19004069 30-Apr-19 18859100 28-Feb-19 18972803 30-Apr-19 19056273 31-May-19 19062764 31-May-19 19003895 30-Apr-19 18973149 30-Apr-19 18956009 31-Mar-19 18893301 28-Feb-19 18894059 28-Feb-19 18860564 28-Feb-19 19003547 30-Apr-19 18955103 31-Mar-19 18942056 31-Mar-19 18886614 28-Feb-19 18894438 28-Feb-19 18941128 31-Mar-19 19083403 31-May-19 18862068 28-Feb-19 18885200 28-Feb-19 19003721 30-Apr-19 19064636 31-May-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 1.5 MM X 4 CM MODEL Number:M0035431540 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: M0035431540: Lot Number/Expiration Date: 18843121 28-Feb-19 18842254 28-Feb-19 18752256 31-Dec-18 18637622 31-Oct-18 18531974 31-Aug-18 18450202 30-Jun-18 18765704 31-Dec-18 18749439 31-Dec-18 18748627 31-Dec-18 18546175 31-Aug-18 18546117 31-Aug-18 18556378 31-Aug-18 18538344 31-Aug-18 18749033 31-Dec-18 18602307 30-Sep-18 18532032 31-Jul-18 18802864 31-Jan-19 18797083 31-Jan-19 18794216 31-Jan-19 18812672 31-Jan-19 18637738 31-Oct-18 18607230 31-Oct-18 18637680 31-Oct-18 18449404 30-Jun-18 18794100 31-Jan-19 18776421 31-Dec-18 18602365 30-Sep-18 18581643 30-Sep-18 18801549 31-Jan-19 18737036 31-Dec-18 18602249 30-Sep-18 18486380 31-Jul-18 18486322 31-Jul-18 19086644 31-May-19 18941592 31-Mar-19 19086586 31-May-19 18973495 30-Apr-19 19004069 30-Apr-19 18859100 28-Feb-19 18972803 30-Apr-19 19056273 31-May-19 19062764 31-May-19 19003895 30-Apr-19 18973149 30-Apr-19 18956009 31-Mar-19 18893301 28-Feb-19 18894059 28-Feb-19 18860564 28-Feb-19 19003547 30-Apr-19 18955103 31-Mar-19 18942056 31-Mar-19 18886614 28-Feb-19 18894438 28-Feb-19 18941128 31-Mar-19 19083403 31-May-19 18862068 28-Feb-19 18885200 28-Feb-19 19003721 30-Apr-19 19064636 31-May-19.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2171-2016
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.