MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC35015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18906029358469), received between Jan 25, 2018 and Jan 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionJan 25, 2018Defective Component; Device Issue; Physical Property Issue; Defective Component; Device Issue; Physical Property Issue

  NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS PREPARED NORMALLY AND THE CATHETER PERFORMED AS EXPECTED WHILE IN THE PATIENT. IT WAS OBSERVED THAT THE MOZEC BALLOON CATHETER STICKING TO INTERVENTIONAL WIRE WHEN REMOVING FROM THE PATIENT. TWO (2) OF 3 BALLOONS USED DURING THE PROCEDURE STUCK TO WIRE ONCE OUTSIDE OF GUIDE/TOUHY BURST. IT TOOK EXTRA EFFORT TO REMOVE FROM WIRE (OUTSIDE PATIENT). THE DEVICE WAS REMOVED AS SINGLE UNIT FROM THE PATIENT AND NO KINK OR BENT WERE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE (MOZEC NC, LOT # MNCF27). NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. PLEASE NOTE: THIS IS THE SECOND REPORT OF TWO FOR THE SAME EVENT. TWO BALLOONS WERE USED AND THIS REPORT IS FOR THE SECOND BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7218959 ↗