Device Recall FlowGate Balloon Guide Catheter; 의 리콜

Recall

63938

Class 2

Z-0655-2013

2012-12-20

2013-01-08

Terminated

United States

2013-02-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115074

Firm received complaints of resistance and possible collapse of the distal tip of the flowgate balloon guide catheters during use for aspiration.

Concentric Medical sent a Urgent Medical Device Recall Notification letter dated December 19, 2012, to all affected customers. The letter identified the product the problme and the action needed to be taken by the customer. Customers were instructed to follow these instructions. 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Concentric Medical (Stryker Neurovascular) can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: Fax it to: 650-237-5230 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. Upon receipt of the returned customer response form, a Stryker Representative will contact you to arrange for credit of returned devices. On behalf of Stryker Neurovascular, we sincerely thank you for your help and support and regret any inconvenience and appreciate your assistance in completing this recall. Should you have any questions concerning this matter please do not hesitate to contact the undersigned.