MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC27515Recalls & reported problems
Meril Life Sciences Private Limited · MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.75 mm x 15 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 18906029358308), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Failure to Deflate1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2023Failure to Advance; Failure to Deflate; Failure to Advance; Failure to Deflate
AS REPORTED, 2.75 X 15 MM, MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. IT HAS BEEN STATED THAT THE FLEXIBILITY AND LESION PASSAGE WERE NOT SUFFICIENT, IT WAS CHALLENGING TO PASS THROUGH THE STENT, BALLOON COMPLIANCE WAS LOW, THE DEFLATION WAS DELAYED DURING THE BALLOON DEFLATION AND THAT THIS WAS NOT SUITABLE FOR USE DUE TO THE INCREASE OF PERIPROCEDURAL MI RISK.
Patient problems: Insufficient Information
MAUDE report 16829434 ↗
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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