MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC45013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18906029359527), received between Oct 21, 2023 and Oct 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2023Deflation Problem; Deflation Problem

  AS REPORTED, 4.50X13 MM MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS MID RCA WITH SEVERE TORTUOSITY, 80% CALCIFICATION AND 80% STENOSIS. THE BALLOON WAS PLACED MID TO PROXIMAL IN THE RCA. THE BALLOON DID NOT DEFLATE DURING THE PROCEDURE. (THE BALLON TOOK 1.5 - 2 MINUTES TO DEFLATE). THE DEVICE WAS USED IN 62 YEARS OLD MALE PATIENT. THE TARGET LESION WAS MID RCA WITH SEVERE TORTUOSITY, 80% CALCIFICATION AND 80% STENOSIS. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY IN REMOVING THE STYLET. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY. THERE WAS NO ANOMALY NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WAS NO UNUSUAL FORCE USED DURING THE LOADING ON GUIDEWIRE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981741 ↗