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.
FDA Recall Z-2218-2010 · Posted 2010-08-18
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Recalling FirmAngioScore Inc.
Recall StatusTerminated
Product CodeNWX
Date Initiated2009-12-04
Date Terminated2011-06-21
Product Quantity3870 units
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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