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
Recall
- Recall Number
- Z-0481-2015
- Event Number
- 69669
- Firm
- Stryker Neurovascular
- FEI Number
- 3008853977
- Product Code
- HCG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 22, 2014
- Posted
- December 16, 2014
- Terminated
- February 12, 2015
- Address
- 47900 Bayside Pkwy, Fremont, CA, 94538-6515
Description
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
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
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 inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: a. Fax it to: 1-866-876-4355 or b. E-mail a copy to: [email protected] c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Stryker Customer Service reps will contact customers to arrange for replacement. Any returned product will be quarantined and destroyed.
US Distribution to the states of: VA, NH, OH and TX.
1 unit