Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA adverse event reports and recall history for catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring (product code NWX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 7,648
- Deaths
- 49
- Injuries
- 435
- Malfunctions
- 7,163
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-08-18TerminatedProcess design
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.
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.
- 2008-01-23TerminatedProcess control
AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
- TerminatedProcess control
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
The incorrect outer carton box was used for the product.
Monitor catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring automatically
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