AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery

FDA device recall Z-2218-2010 · posted 2010-08-18 · Terminated

Recall details

Recalling firm

AngioScore Inc.

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.

Action taken

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

Status

Terminated

Product code

NWX

Quantity affected

3870 units

Distribution

Nationwide distribution.

Date initiated

2009-12-04

Date posted

2010-08-18

Date terminated

2011-06-21

Location

Fremont, CA