MozecTM Rx PTCA Balloon Dilatation Catheter MOZ22533Recalls & reported problems
Meril Life Sciences Private Limited · MozecTM Rx PTCA Balloon Dilatation Catheter, 2.25 mm x 33 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 18904224907666), 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 Remove1
- Entrapment of Device1
- Mechanical Problem1
- Physical Resistance1
- 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, 2018Entrapment of Device; Mechanical Problem; Difficult to Remove; Sticking; Device Issue; Physical Resistance; Entrapment of Device; Mechanical Problem; Difficult to Remove; Sticking; Device Issue; Physical Resistance
PHYSICIAN USED A SEMI COMPLIANT MOZEC BALLOON TO PRE-DILATE IN THE RCA. AFTER DEFLATING THE BALLOON, WHILE PULLING BACK THE BALLOON CATHETER, PHYSICIAN NOTICED IT WAS SOMEWHAT DIFFICULT TO PULL OUT, HOWEVER THE WIRE WAS MOVING. PHYSICIAN LOOKED UNDER FLUORO AND OBSERVED THAT THE WIRE WAS NOT PAST THE BALLOON CATHETER, THUS, WIRE CAME OUT BEFORE THE BALLOON BECAUSE SEMI COMPLIANT MOZEC BALLOON WAS STUCK ON THE WIRE. HAD TO PULL WIRE OUT WITH MOZEC BALLOON STUCK ON IT. HAD TO USE ANOTHER WIRE TO COMPLETE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7335092 ↗
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- 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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