MozecTM Rx PTCA Balloon Dilatation Catheter MOZ15012Recalls & reported problems
Meril Life Sciences Private Limited · MozecTM Rx PTCA Balloon Dilatation Catheter, 1.50 mm x 12 mm, Rapid Exchange · Class 2
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 18904224907550), received between Mar 13, 2018 and Mar 13, 2018 — 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 Advance1
- Difficult to Remove1
- Failure to Advance1
- Physical Resistance1
- Positioning Problem1
- Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2018Difficult to Remove; Sticking; Device Issue; Failure to Advance; Physical Resistance; Difficult to Advance; Positioning Problem; Difficult to Remove; Sticking; Device Issue; Failure to Advance; Physical Resistance; Difficult to Advance; Positioning Problem
PHYSICIAN REPORTED USING A SEMI COMPLIANT MOZEC BALLOON DURING A CORONARY CTO CASE. BALLOON WAS DIFFICULT TO DELIVER BUT WAS ABLE TO PRE-DILATE LESION. AFTER DEFLATING SEMI COMPLIANT MOZEC BALLOON, WHILE WORKING BACK THE BALLOON CATHETER, IT WAS TIGHT ON THE WIRE. WAS ABLE TO GET BACK TO GUIDE AND TUOHEY, BUT COULDN'T GET MUCH PAST MONORAIL. CONCLUDED SEMI COMPLAINT MOZEC BALLOON WAS STUCK ON THE WIRE. IN ORDER TO REMOVE, HAD TO PINCH WIRE TO REMOVE MOZEC BALLOON FROM THE WIRE. THUS, MOZEC BALLOON WAS STUCK ON THE WIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7335057 ↗
Other Catheters, Transluminal Coronary Angioplasty, Percutaneous devices
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- 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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