GDC-10 360 SOFT 3mm x 6cm SR ; 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
Reported: December 10, 2014 Initiated: October 22, 2014 #Z-0478-2015
Product Description
GDC-10 360 SOFT 3mm x 6cm SR ; 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
Reason for Recall
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Details
- Recalling Firm
- Stryker Neurovascular
- Units Affected
- 1
- Distribution
- US Distribution to the states of: VA, NH, OH and TX.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
GDC-10 360 SOFT 3mm x 6cm SR ; 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. Recalled by Stryker Neurovascular. Units affected: 1.
Why was this product recalled? ▼
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Moderate. Recall number: Z-0478-2015.
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