Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradi
FDA device recall Z-2030-2010 · posted 2010-07-17 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- Reason for recall
- 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
- Action taken
- 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 the product therefore replacements will not be available. Devices can be returned to Medtronic CardioVascular, 7611 Northland Drive, Brooklyn Park, MN 55428. The customers were ask to please fill out the Medtronic Recall Certificate and fax it to 651-367-2620. If you need additional information, please contact CardioVascular LifeLine Technical Services at 877-526-7890, or you local Medtronic sales representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- FZP
- Quantity affected
- 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 a
- Date initiated
- 2010-04-02
- Date posted
- 2010-07-17
- Date terminated
- 2011-12-17
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (K031623) | Coalescent Surgical | 2003-07-03 |