Recall Z-0763-06 ยท FZP Clip, Implantable
Medtronic Cardiac Surgery Technologies
Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis.
| Date | Apr 13, 2006 (initiated Sep 1, 2005) |
| Status | Terminated |
| Reason | Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips. |
| Root cause | Other |
| Action | A letter and response certificate disseminated to all customers describing problem and recommending return of Spyder devices in inventory. September 1, 2005. |
| Quantity | 3383 |
| Distribution | Nationwide (AZ, CA, CT, FL, HI, IA, ID, IL, IN, KS, KY, LA, ,MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, TN, TX, UT, WA, WI, WV). Japan, Belgium, Netherlands, Singapore, and Thailand. |
| FDA record | Open on fda.gov |