Recall Z-0478-2015— 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: K103355. Product: 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: 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.