MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC30015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18906029358384), received between Mar 12, 2018 and Dec 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  AS REPORTED, 3.00 X 15 MM MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. IT HAS BEEN STATED THE TRANSITION PROFILE WAS INSUFFICIENT IN THE TRANSITION INTO THE VESSEL AND STENT, THE PROCEDURES WERE FAILURE DUE TO LACK OF SUFFICIENT FLEXIBILITY AND LUBRICITY, THE BALLOON COMPLIANCE WAS LIMITED AND THE RISK OF PROCEDURAL MYOCARDIAL INFARCTION INCREASED DUE TO THE DELAY EXPERIENCED DUE TO THE PROBLEM IN RETRACTION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15967847 ↗
• MalfunctionMar 16, 2020Retraction Problem; Retraction Problem

  AS REPORTED, 3.00 X 15MM MOZEC(TM) NC RX PTCA BALLOON DILATATION CATHETER, BATCH #: MNCO52 WAS USED IN A PCI. WHILE WITHDRAWING, IT WAS VERY DIFFICULT TO RETRIEVE WITHOUT TAKING THE GUIDE WIRE. THIS INCREASE THE RADIATION TIME.

  Patient problems: No Information

  MAUDE report 9834371 ↗
• MalfunctionMar 12, 2018Difficult to Remove; Device Operational Issue; Human Factors Issue; Human-Device Interface Problem; Positioning Problem; Difficult to Remove; Device Operational Issue; Human Factors Issue; Human-Device Interface Problem; Positioning Problem

  PHYSICIAN USED A 3.0X15 MOZEC NC TO PRE-DILATE DURING A CORONARY INTERVENTION PROCEDURE. EVERYTHING WAS FINE GETTING THE BALLOON TO THE LESION SINCE IT WAS STILL NOT INFLATED. WHEN THEY WENT TO INFLATE MOZEC NC BALLOON, IT WOULD NOT MOVE AND WAS OBSERVED TO BE FUSED TO THE WIRE. THE PHYSICIAN REPORTED HAVING SOME DIFFICULTY GETTING THE WIRE AND BALLOON OUT, BUT EVENTUALLY WAS ABLE TO REMOVE THE WIRE AND THE MOZEC NC BALLOON THAT WAS STUCK ON IT. UNFORTUNATELY THEY DID NOT SAVE THE MOZEC NC BALLOON AND THREW OUT THE WIRE WITH THE MOZEC NC BALLOON STUCK ON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330372 ↗