Recall Z-2030-2010 ยท FZP Clip, Implantable
Medtronic Cardiovascular Revascularization & Surgical Therap
Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from
| Date | Jul 17, 2010 (initiated Apr 2, 2010) |
| Status | Terminated |
| Reason | Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. While this issue does not impact performance of the clip once implanted, separation of |
| Root cause | Other |
| Action | The firm, Medtronic CardioVascular, sent an "Urgent Medical Device Recall Notice", dated April 2, 2010, to Risk Managers of each affected account. The letter described the issue, identified affected product, and the action to be taken by customers. The customers were ask to immediately discontinue use of affected devices and to quarantine all unused V100D U-Clip inventory. The letter stated that a Medtronic representative will contact the account to arrange return of the V100D U-Clips devices and that credit will be issued upon return of unused devices. Medtronic has stopped manufacture of |
| Quantity | 22,946 ( 20,714 US, 2,232 OUS) |
| Distribution | Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and countries of Australia, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Japa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031623 | MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES Coalescent Surgical, Jul 3, 2003 |