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U.S. Department of Health and Human Services

Class 1 Device Recall AngioSculpt PTA Scoring Balloon Catheter

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 Class 1 Device Recall AngioSculpt PTA Scoring Balloon Cathetersee related information
Date Initiated by FirmNovember 16, 2010
Date PostedJanuary 04, 2011
Recall Status1 Terminated 3 on October 04, 2011
Recall NumberZ-0840-2011
Recall Event ID 57271
510(K)NumberK103003 K072225 K080151 
Product Classification vascular balloon catheter - Product Code DQY
ProductAngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020.
Code Information Part (REF) number: 2076-6020: All lot codes
FEI Number 3005462046
Recalling Firm/
Manufacturer		 AngioScore Inc.
5055 Brandin Ct
Fremont CA 94538-3140
For Additional Information ContactKarin 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
ActionMedical 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 Commerce17682 units, all sizes and lots
DistributionWorldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = DQY
510(K)s with Product Code = DQY
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