Recall Z-0842-2011 ยท DQY Catheter, Percutaneous
AngioScore Inc.
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020
| Date | Jan 4, 2011 (initiated Nov 16, 2010) |
| Status | Terminated |
| Reason | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. |
| Root cause | Device Design |
| Action | Medical Device Recall notifications were sent to all domestic consignees on Nov 16, 2010 by overnight mail. Foreign distributors, other than Japan, were sent recall letters by e-mail or international overnight delivery on November 16, 2010. The Japanese distributor received notification and notified their customers on November 10, 2010. |
| Quantity | 17682 units, all sizes and lots |
| Distribution | Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom |
| FDA record | Open on fda.gov |