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U.S. Department of Health and Human Services

Class 1 Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore

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  Class 1 Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore see related information
Date Initiated by Firm December 04, 2009
Date Posted August 18, 2010
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-2218-2010
Recall Event ID 54687
PMA Number P050018 
Product Classification Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring - Product Code NWX
Product AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA.
Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.
Code Information Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003
Recalling Firm/
Manufacturer		 AngioScore Inc.
5055 Brandin Ct
Fremont CA 94538-3140
For Additional Information Contact
510-933-7904
Manufacturer Reason
for Recall		 Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.
FDA Determined
Cause 2		 Process design
Action AngioScore sent an "Urgent: Medical Device Voluntary Recall" dated December 4, 2009 addressed to "Catheterization Lab Manager" at consignees. The Recall notification letter instructed consignees to inspect their inventory to detect product from the involved lot, and segregate it from their inventory. Consignees were asked to record all affected product and fax return forms to the firm. AngioScore Customer Service will contact consignees and provide instructions for return and replacement of affected product.. Consignees can contact AngioScore at 877-264-4692.
Quantity in Commerce 3870 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = NWX and Original Applicant = SPECTRANETICS CORP.
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