Recall Z-0481-2015— Stryker Neurovascular
Class II · Terminated
Class II FDA medical device recall by Stryker Neurovascular, initiated 2014-10-22, terminated 2015-02-12. It names one FDA 510(k) clearance: K120850. Product: Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: " Intracranial aneurysms " Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae " Arterial and venous embolizations in the peripheral vasculature. Reason: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date..
- Recalling firm
- Stryker Neurovascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-22
- Terminated
- 2015-02-12
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: " Intracranial aneurysms " Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae " Arterial and venous embolizations in the peripheral vasculature
Reason for recall
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.