MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC20015Recalls & reported problems
Meril Life Sciences Private Limited · MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.00 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 18906029358063), received between Sep 17, 2018 and Sep 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2018Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking
THE SURGEON USED A 2.0X15 MOZEC NC TO PRE-DILATE A LESION DURING A CORONARY INTERVENTION. THE BALLOON WAS INFLATED AND DEFLATED FOUR ( 4) TIMES. WHEN TRYING TO REMOVE THE BALLOON, IT GOT STUCK ON THE SION BLUE WIRE. THE SION BLUE WIRE WAS REMOVED WITH MOZEC BALLOON STILL ON IT. THE VESSEL WAS RE-WIRED TO COMPLETE THE PROCEDURE WITH A NON-MERIL DEVICE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7882779 ↗
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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