Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 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:M0035443560: Lot Number/Expiration Date: 18736425 31-Dec-18 18521457 31-Jul-18 18838703 31-Jan-19 18703233 30-Nov-18 18443288 30-Jun-18 18735209 30-Nov-18 18659056 31-Oct-18 18781251 31-Jan-19 18801665 31-Jan-19 18747459 31-Dec-18 18802980 31-Jan-19 18659087 31-Oct-18 18649087 31-Oct-18 18536525 31-Aug-18 19046694 31-May-19 19047725 31-May-19 18875709 28-Feb-19 18987089 30-Apr-19 19006438 30-Apr-19 18959391 31-Mar-19 18936943 31-Mar-19 19022830 30-Apr-19 18984771 30-Apr-19 18922696 31-Mar-19 18898321 28-Feb-19 19061363 31-May-19 18853805 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 3.5 MM X 6CM MODEL Number:M0035443560 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:M0035443560: Lot Number/Expiration Date: 18736425 31-Dec-18 18521457 31-Jul-18 18838703 31-Jan-19 18703233 30-Nov-18 18443288 30-Jun-18 18735209 30-Nov-18 18659056 31-Oct-18 18781251 31-Jan-19 18801665 31-Jan-19 18747459 31-Dec-18 18802980 31-Jan-19 18659087 31-Oct-18 18649087 31-Oct-18 18536525 31-Aug-18 19046694 31-May-19 19047725 31-May-19 18875709 28-Feb-19 18987089 30-Apr-19 19006438 30-Apr-19 18959391 31-Mar-19 18936943 31-Mar-19 19022830 30-Apr-19 18984771 30-Apr-19 18922696 31-Mar-19 18898321 28-Feb-19 19061363 31-May-19 18853805 28-Feb-19.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2177-2016
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.