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Stryker Neurovascular recalls Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flo
Recalled December 10, 2014 · FDA recall Z-0481-2015 · Stryker Neurovascular
Hazard
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. · FDA Class II
Units
1 unit
Sold at
US Distribution to the states of: VA, NH, OH and TX.
Description
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
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
Manufacturer(s)
Stryker Neurovascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →