Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 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: M0035443060: Lot Number/Expiration Date: 18826753 31-Jan-19 18826606 31-Jan-19 18794421 31-Jan-19 18777349 31-Dec-18 18750808 31-Dec-18 18754448 31-Dec-18 18760112 31-Dec-18 18491003 31-Jul-18 18443198 30-Jun-18 18827047 31-Jan-19 18816704 31-Jan-19 18776301 31-Dec-18 18750603 31-Dec-18 18491065 31-Jul-18 18442058 30-Jun-18 18808498 31-Jan-19 18783540 31-Jan-19 18764659 31-Dec-18 18750193 31-Dec-18 18708724 30-Nov-18 18491096 31-Jul-18 18443258 30-Jun-18 18443228 30-Jun-18 18393950 31-May-18 18817367 31-Jan-19 18782584 31-Jan-19 18755514 31-Dec-18 18703469 30-Nov-18 18443018 30-Jun-18 18442958 30-Jun-18 18442538 30-Jun-18 18441728 30-Jun-18 18436622 30-Jun-18 18827341 31-Jan-19 18809086 31-Jan-19 18809674 31-Jan-19 18765615 31-Dec-18 18750398 31-Dec-18 18471007 31-Jul-18 18490724 31-Jul-18 18818030 31-Jan-19 18760113 31-Dec-18 18708786 30-Nov-18 18490972 31-Jul-18 18442508 30-Jun-18 18442268 30-Jun-18 18827194 31-Jan-19 18703264 30-Nov-18 18490910 31-Jul-18 18442568 30-Jun-18 18827488 31-Jan-19 18826900 31-Jan-19 18808792 31-Jan-19 18443048 30-Jun-18 19013252 30-Apr-19 19000510 30-Apr-19 18951824 31-Mar-19 18853836 28-Feb-19 19028176 30-Apr-19 18990655 30-Apr-19 19041022 31-May-19 19040295 31-May-19 19000572 30-Apr-19 18960708 31-Mar-19 18902391 28-Feb-19 19013163 30-Apr-19 19066272 31-May-19 19063700 31-May-19 18975258 30-Apr-19 18974821 30-Apr-19 18905927 31-Mar-19 19028296 30-Apr-19 19013074 30-Apr-19 18952060 31-Mar-19 18951116 31-Mar-19 18905896 28-Feb-19 18901749 28-Feb-19 18990624 30-Apr-19 18952296 31-Mar-19 19028056 30-Apr-19 19012985 30-Apr-19 18975695 30-Apr-19 18943458 31-Mar-19 18926529 31-Mar-19 18903033 28-Feb-19 19027936 30-Apr-19 19039567 31-May-19 19000541 30-Apr-19 18960301 31-Mar-19 18951588 31-Mar-19 18943981 31-Mar-19 18883033 28-Feb-19 18925429 31-Mar-19 18944504 31-Mar-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 6CM MODEL Number:M0035443060 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: M0035443060: Lot Number/Expiration Date: 18826753 31-Jan-19 18826606 31-Jan-19 18794421 31-Jan-19 18777349 31-Dec-18 18750808 31-Dec-18 18754448 31-Dec-18 18760112 31-Dec-18 18491003 31-Jul-18 18443198 30-Jun-18 18827047 31-Jan-19 18816704 31-Jan-19 18776301 31-Dec-18 18750603 31-Dec-18 18491065 31-Jul-18 18442058 30-Jun-18 18808498 31-Jan-19 18783540 31-Jan-19 18764659 31-Dec-18 18750193 31-Dec-18 18708724 30-Nov-18 18491096 31-Jul-18 18443258 30-Jun-18 18443228 30-Jun-18 18393950 31-May-18 18817367 31-Jan-19 18782584 31-Jan-19 18755514 31-Dec-18 18703469 30-Nov-18 18443018 30-Jun-18 18442958 30-Jun-18 18442538 30-Jun-18 18441728 30-Jun-18 18436622 30-Jun-18 18827341 31-Jan-19 18809086 31-Jan-19 18809674 31-Jan-19 18765615 31-Dec-18 18750398 31-Dec-18 18471007 31-Jul-18 18490724 31-Jul-18 18818030 31-Jan-19 18760113 31-Dec-18 18708786 30-Nov-18 18490972 31-Jul-18 18442508 30-Jun-18 18442268 30-Jun-18 18827194 31-Jan-19 18703264 30-Nov-18 18490910 31-Jul-18 18442568 30-Jun-18 18827488 31-Jan-19 18826900 31-Jan-19 18808792 31-Jan-19 18443048 30-Jun-18 19013252 30-Apr-19 19000510 30-Apr-19 18951824 31-Mar-19 18853836 28-Feb-19 19028176 30-Apr-19 18990655 30-Apr-19 19041022 31-May-19 19040295 31-May-19 19000572 30-Apr-19 18960708 31-Mar-19 18902391 28-Feb-19 19013163 30-Apr-19 19066272 31-May-19 19063700 31-May-19 18975258 30-Apr-19 18974821 30-Apr-19 18905927 31-Mar-19 19028296 30-Apr-19 19013074 30-Apr-19 18952060 31-Mar-19 18951116 31-Mar-19 18905896 28-Feb-19 18901749 28-Feb-19 18990624 30-Apr-19 18952296 31-Mar-19 19028056 30-Apr-19 19012985 30-Apr-19 18975695 30-Apr-19 18943458 31-Mar-19 18926529 31-Mar-19 18903033 28-Feb-19 19027936 30-Apr-19 19039567 31-May-19 19000541 30-Apr-19 18960301 31-Mar-19 18951588 31-Mar-19 18943981 31-Mar-19 18883033 28-Feb-19 18925429 31-Mar-19 18944504 31-Mar-19.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2176-2016
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.