MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC25028Recalls & reported problems
Meril Life Sciences Private Limited · MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.50 mm x 28 mm, Rapid Exchange · Class 2
All models of MozecTM NC Rx PTCA Balloon Dilatation Catheter (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18906029358254), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Issue” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Issue1
- Difficult to Remove1
- Mechanical Jam1
- Positioning Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2017Difficult to Remove; Device Issue; Mechanical Jam; Positioning Problem; Difficult to Remove; Device Issue; Mechanical Jam; Positioning Problem
MOZECTM NC RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) 2.50MM X 28MM WAS TRACKED OVER A NON-CORDIS WIRE AND INFLATED AT TWENTY ATMOSPHERES (20ATM). THE BALLOON INITIALLY TACKED WELL OVER THE WIRE BUT AFTER MULTIPLE INFLATIONS, WHEN THE USER WAS PULLING THE BALLOON OUT, THE WIRE GOT STUCK INTO THE BALLOON. THE BALLOON AND THE WIRE WERE REMOVED TOGETHER AND THE BALLOON WAS REWIRED. THE PROCEDURE WAS CONDUCTED FOR A CHRONIC TOTAL OCCLUSION (CTO) OF THE LEFT ANTERIOR DESCENDING (LAD). NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: No Information
MAUDE report 7033679 ↗
Other Catheters, Transluminal Coronary Angioplasty, Percutaneous devices
- MINI TREK™ 1012270-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous223 reports
- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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