AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Par
FDA device recall Z-0839-2011 · posted 2011-01-04 · Terminated
Recall details
- Recalling firm
- AngioScore Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 17682 units, all sizes and lots
- Distribution
- Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
- Date initiated
- 2010-11-16
- Date posted
- 2011-01-04
- Date terminated
- 2011-10-04
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM (K103003) | Aesculap, Inc. | 2010-11-09 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 (K080151) | Angioscore, Inc. | 2008-04-25 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K072225) | Angioscore, Inc. | 2007-10-12 |