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Class 1 Device Recall AngioSculpt PTA Scoring Balloon Catheter |
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Date Initiated by Firm |
November 16, 2010 |
Date Posted |
January 04, 2011 |
Recall Status1 |
Terminated 3 on October 04, 2011 |
Recall Number |
Z-0842-2011 |
Recall Event ID |
57271 |
510(K)Number |
K103003 K072225 K080151
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Product Classification |
vascular balloon catheter - Product Code DQY
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Product |
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 |
Code Information |
Part (REF) number: 2105-6020: 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
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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.
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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 and Original Applicant = AESCULAP, INC. 510(K)s with Product Code = DQY and Original Applicant = ANGIOSCORE, INC.
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