Device product
Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Z-2179-2016
Product summary
- Event
- Event 74425
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,302 (8,188 in the U.S.) - total, all model numbers
- Official record key
device-enforcement:Z-2179-2016
Official wording
Reason: 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.
Code information: MODEL Number::M0035452030; Lot Number/Expiration Date: 19032837 30-Apr-19 19034203 31-May-19 18953644 31-Mar-19 19032930 30-Apr-19 18986505 30-Apr-19 18922370 31-Mar-19 18987445 30-Apr-19 18972051 30-Apr-19 18971500 30-Apr-19 18905990 31-Mar-19 19060369 31-May-19.
Distribution pattern: Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
Derived failure modes
-
Unknown
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.