| Class 1 Device Recall AngioSculpt PTA Scoring Balloon Catheter | |
Date Initiated by Firm | November 16, 2010 |
Date Posted | January 04, 2011 |
Recall Status1 |
Terminated 3 on October 04, 2011 |
Recall Number | Z-0841-2011 |
Recall Event ID |
57271 |
510(K)Number | K072225 K080151 K103003 |
Product Classification |
vascular balloon catheter - Product Code DQY
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Product | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020. |
Code Information |
Part (REF) number: 2092-6020: All lot codes |
Recalling Firm/ Manufacturer |
AngioScore Inc. 5055 Brandin Ct Fremont CA 94538-3140
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For Additional Information Contact | Karin J. Gastineau 877-264-4692 |
Manufacturer 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 2 | 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 in Commerce | 17682 units, all sizes and lots |
Distribution | Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQY 510(K)s with Product Code = DQY
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