Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    MODEL Number: M0035442030: Lot Number/Expiration Date: 18824618 31-Jan-19 18789433 31-Jan-19 18789313 31-Jan-19 18567759 31-Aug-18 18809910 31-Jan-19 18758958 31-Dec-18 18727834 30-Nov-18 18643654 31-Oct-18 18583601 31-Aug-18 18516768 31-Jul-18 18440858 30-Jun-18 18824978 31-Jan-19 18770574 31-Dec-18 18679027 30-Nov-18 18654466 31-Oct-18 18554671 31-Aug-18 18727594 30-Nov-18 18702335 30-Nov-18 18679058 30-Nov-18 18554733 31-Aug-18 18583632 30-Sep-18 18824858 31-Jan-19 18816099 31-Jan-19 18789193 31-Jan-19 18770164 31-Dec-18 18721125 30-Nov-18 18667475 31-Oct-18 18470167 31-Jul-18 18440828 30-Jun-18 18770369 31-Dec-18 18758838 31-Dec-18 18740007 31-Dec-18 18654404 31-Oct-18 18515390 31-Jul-18 18824738 31-Jan-19 18789553 31-Jan-19 18727714 30-Nov-18 18567790 31-Aug-18 18489524 31-Jul-18 18462508 30-Jun-18 18434346 30-Jun-18 18810270 31-Jan-19 18810150 31-Jan-19 18810030 31-Jan-19 18816010 31-Jan-19 18740154 31-Dec-18 18715530 30-Nov-18 18702304 30-Nov-18 18654497 31-Oct-18 18437093 30-Jun-18 18437033 30-Jun-18 18992597 30-Apr-19 19071307 31-May-19 18946838 31-Mar-19 18897907 28-Feb-19 18869664 28-Feb-19 18847712 31-Jan-19 18992628 30-Apr-19 19045040 31-May-19 19044951 31-May-19 19071071 31-May-19 19014571 30-Apr-19 18933425 31-Mar-19 18933692 31-Mar-19 18947016 31-Mar-19 18897814 28-Feb-19 18869810 28-Feb-19 18881694 28-Feb-19 19054629 31-May-19 19054753 31-May-19 19014726 30-Apr-19 18869869 31-Mar-19 18881787 28-Feb-19 18848068 31-Jan-19 19044862 31-May-19 19014602 30-Apr-19 18976136 30-Apr-19 18961238 31-Mar-19 18911301 28-Feb-19 18933603 31-Mar-19 19045129 31-May-19 19014664 30-Apr-19 18961118 31-Mar-19 18947105 31-Mar-19 18946927 31-Mar-19 18897876 28-Feb-19 18869748 28-Feb-19 18881725 28-Feb-19 18992659 30-Apr-19 19054691 31-May-19 19030837 30-Apr-19 19054815 31-May-19 19065247 31-May-19 19071543 31-May-19 19014633 30-Apr-19 18976225 30-Apr-19 18976047 30-Apr-19 18911332 28-Feb-19 18869954 28-Feb-19 18881663 28-Feb-19 18881756 28-Feb-19 19054877 31-May-19 19030570 30-Apr-19 19030481 30-Apr-19 19014695 30-Apr-19 18975958 30-Apr-19 18897938 28-Feb-19 18950354 31-Mar-19 18946749 31-Mar-19 18897845 28-Feb-19 19030926 30-Apr-19 18992690 30-Apr-19 19030659 30-Apr-19 19045218 31-May-19 18933514 31-Mar-19 18950416 31-Mar-19 18933336 31-Mar-19 18911270 28-Feb-19 18848246 28-Feb-19 18847890 28-Feb-19.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 2MM X 3CM MODEL Number:M0035442030 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: M0035442030: Lot Number/Expiration Date: 18824618 31-Jan-19 18789433 31-Jan-19 18789313 31-Jan-19 18567759 31-Aug-18 18809910 31-Jan-19 18758958 31-Dec-18 18727834 30-Nov-18 18643654 31-Oct-18 18583601 31-Aug-18 18516768 31-Jul-18 18440858 30-Jun-18 18824978 31-Jan-19 18770574 31-Dec-18 18679027 30-Nov-18 18654466 31-Oct-18 18554671 31-Aug-18 18727594 30-Nov-18 18702335 30-Nov-18 18679058 30-Nov-18 18554733 31-Aug-18 18583632 30-Sep-18 18824858 31-Jan-19 18816099 31-Jan-19 18789193 31-Jan-19 18770164 31-Dec-18 18721125 30-Nov-18 18667475 31-Oct-18 18470167 31-Jul-18 18440828 30-Jun-18 18770369 31-Dec-18 18758838 31-Dec-18 18740007 31-Dec-18 18654404 31-Oct-18 18515390 31-Jul-18 18824738 31-Jan-19 18789553 31-Jan-19 18727714 30-Nov-18 18567790 31-Aug-18 18489524 31-Jul-18 18462508 30-Jun-18 18434346 30-Jun-18 18810270 31-Jan-19 18810150 31-Jan-19 18810030 31-Jan-19 18816010 31-Jan-19 18740154 31-Dec-18 18715530 30-Nov-18 18702304 30-Nov-18 18654497 31-Oct-18 18437093 30-Jun-18 18437033 30-Jun-18 18992597 30-Apr-19 19071307 31-May-19 18946838 31-Mar-19 18897907 28-Feb-19 18869664 28-Feb-19 18847712 31-Jan-19 18992628 30-Apr-19 19045040 31-May-19 19044951 31-May-19 19071071 31-May-19 19014571 30-Apr-19 18933425 31-Mar-19 18933692 31-Mar-19 18947016 31-Mar-19 18897814 28-Feb-19 18869810 28-Feb-19 18881694 28-Feb-19 19054629 31-May-19 19054753 31-May-19 19014726 30-Apr-19 18869869 31-Mar-19 18881787 28-Feb-19 18848068 31-Jan-19 19044862 31-May-19 19014602 30-Apr-19 18976136 30-Apr-19 18961238 31-Mar-19 18911301 28-Feb-19 18933603 31-Mar-19 19045129 31-May-19 19014664 30-Apr-19 18961118 31-Mar-19 18947105 31-Mar-19 18946927 31-Mar-19 18897876 28-Feb-19 18869748 28-Feb-19 18881725 28-Feb-19 18992659 30-Apr-19 19054691 31-May-19 19030837 30-Apr-19 19054815 31-May-19 19065247 31-May-19 19071543 31-May-19 19014633 30-Apr-19 18976225 30-Apr-19 18976047 30-Apr-19 18911332 28-Feb-19 18869954 28-Feb-19 18881663 28-Feb-19 18881756 28-Feb-19 19054877 31-May-19 19030570 30-Apr-19 19030481 30-Apr-19 19014695 30-Apr-19 18975958 30-Apr-19 18897938 28-Feb-19 18950354 31-Mar-19 18946749 31-Mar-19 18897845 28-Feb-19 19030926 30-Apr-19 18992690 30-Apr-19 19030659 30-Apr-19 19045218 31-May-19 18933514 31-Mar-19 18950416 31-Mar-19 18933336 31-Mar-19 18911270 28-Feb-19 18848246 28-Feb-19 18847890 28-Feb-19.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2172-2016

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.

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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.

Apr 18, 2024 Diagnostic Equipment Nationwide View Details →

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.

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