MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC35008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18906029358438), received between Apr 9, 2021 and Apr 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionApr 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED, THE 3.50 X 08 MOZEC NC BALLOON BECAME LODGED ON THE PCI WIRE AND WAS UNABLE TO BE ADVANCED OR REMOVED. THE BALLOON AND WIRE HAD TO BE REMOVED FROM THE PATIENT. ONCE OUT OF THE PATIENT, THE BALLOON WAS STILL LODGED ON THE WIRE AND COULD NOT BE REMOVED. THE PCI WIRE USED WAS A 0.014" BALANCED MIDDLE WEIGHT (BMW) WIRE. A NEW BMW WIRE WAS USED ALONG WITH A 3.5 X 8 NC QUANTUM BALLOON (BOSTON SCI) TO COMPLETE THE CASE. THERE WAS NO ADVERSE EVENT OR HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT. THE SHEATH USED WAS A 6F RAIN SHEATH IN THE RIGHT RADIAL ARTERY. THE GUIDING CATHETER USED WAS A 6F XB3.5 VISTA BRITE TIP GUIDING CATHETER. THE BALLOON CATHETER WAS PREPPED IN THE USUAL FASHION PER THE IFU. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER PRIOR TO LOADING ON THE WIRE. THE BALLOON WAS NEVER INFLATED, AS IT BECAME LODGED ON THE WIRE PRIOR TO EXITING THE GUIDING CATHETER. THE BALLOON CATHETER WAS STORED ON A SUPPLY CART IN THE PROCEDURE AREA WITH CONTROLLED TEMPERATURE AND HUMIDITY. THE DEVICE WAS USED FOR THE 87 YEARS OLD PERSON WEIGHING 68 KG. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY IN REMOVING THE PROTECTIVE BALLOON COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640076 ↗