MozecTM Rx PTCA Balloon Dilatation Catheter MOZ20015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18904224907598), received between Apr 16, 2018 and Mar 9, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  AN ANGIOGRAPHY WAS PERFORMED ON CORONARY ARTERIES WHICH DETERMINED THAT THE LAD WAS SUB TOTALLY OCCLUDED. A PCI WAS PERFORMED ON LAD OF A FEMALE AGED (B)(6) YEARS. IT TOOK 20-30 MINUTES TO SUCCESSFULLY WIRE THE LAD WITH AN ABBOTT POWERTURN FLEX 0.014", 190CM INTERVENTIONAL CORONARY WIRE. UPON SUCCESSFUL WIRING OF THE LAD, A 2.00 X 15 MM MOZEC WAS PLACED ONTO THE WIRE AND BECAME STUCK (UNABLE TO ADVANCE OR RETRACT) OUTSIDE OF THE GUIDING CATHETER. THE WIRE WAS LUBRICATED WITH SALINE AT ALL TIMES OUTSIDE OF THE GUIDING CATHETER. UPON ATTEMPTING TO RETRACT THE MOZEC BALLOON OFF THE WIRE, THE BALLOON AND DELIVERY CATHETER HYPOTUBE BECAME DETACHED. AT THIS TIME THE HYPOTUBE WAS REMOVED WHILE THE ACTUAL BALLOON WAS STUCK ON THE WIRE. THE WIRE WAS THEN CUT WITH AN ATTEMPT TO REMOVE THE STUCK BALLOON ON THE WIRE AND ADVANCE ANOTHER BALLOON ON THE SAME WIRE WHICH WAS UNSUCCESSFUL. THE WIRE WAS ULTIMATELY REMOVED AND THE VESSEL WAS REWIRED WITH A DIFFERENT ABBOTT POWERTURN FLEX 0.014", 190 CM INTERVENTIONAL CORONARY WIRE AND THE PROCEDURE WAS COMPLETED USING BOSTON SCIENTIFIC 2.0 X 20 MM RX EMERGE PTCA BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8406349 ↗
• MalfunctionApr 16, 2018Off-Label Use; Device Slipped; Device Issue; Detachment of Device or Device Component; Device Dislodged or Dislocated; Human Factors Issue; Physical Property Issue; Off-Label Use; Device Slipped; Device Issue; Detachment of Device or Device Component; Device Dislodged or Dislocated; Human Factors Issue; Physical Property Issue

  THE TIP OF THE BALLOON CAME OFF WHILE TRYING TO RELOAD THE BALLOON ON THE WIRE FOR A SECOND INFLATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7432832 ↗