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Stryker Neurovascular recalls GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that
Recalled December 10, 2014 · FDA recall Z-0480-2015 · 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
GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable
Manufacturer(s)
Stryker Neurovascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →