Recall Z-0478-2015 ยท HCG Device, Neurovascular Embolization
Stryker Neurovascular
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
| Date | Dec 16, 2014 (initiated Oct 22, 2014) |
| Status | Terminated |
| Reason | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. |
| Root cause | Process control |
| Action | Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters request that users take the following actions: 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Stryker Neurovascular can infor |
| Quantity | 1 |
| Distribution | US Distribution to the states of: VA, NH, OH and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103355 | GDC 360 DETEACHABLE COIL Boston Scientific Corp, Feb 16, 2011 |