Recall Z-0839-2011
AngioScore Inc. · initiated November 16, 2010
Product
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020.
Codes / lots: Part (REF) number: 2076-5020: All lot codes
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0839-2011
- Initiated
- November 16, 2010
- Posted by FDA
- January 4, 2011
- Terminated
- October 4, 2011
- Product code
- DQY – Catheter, Percutaneous
- Quantity
- 17682 units, all sizes and lots
- Distribution
- Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
- Recalling firm
- AngioScore Inc., Fremont, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0838-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-0840-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-0841-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-0842-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |