MozecTM Rx PTCA Balloon Dilatation Catheter MOZ20012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18904224907581), received between May 1, 2018 and Jan 16, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2019Material Deformation; Material Twisted/Bent; Physical Resistance/Sticking; Material Deformation; Material Twisted/Bent; Physical Resistance/Sticking

  THE TARGET LESION WAS SEVERELY CALCIFIED AND MODERATELY TORTUOUS. THE DEVICE WAS PREPPED NORMAL AS PER THE IFU. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO THE INSERTION OF THE PRODUCT INTO THE PATIENT. THE PHYSICIAN EXPERIENCED RESISTANCE/FRICTION WHILE CROSSING THE TARGET LESION AND THE DEVICE FAILED TO CROSS THE LESION. NO INFLATION/DEFLATION WERE PERFORMED. THE CATHETER WAS THEN RETRACTED FROM THE PATIENT, WHILE REMOVING NO EXCESS FORCE WAS USED. UPON REMOVAL FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE RX PORT WAS EXTREMELY TWISTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254271 ↗
• MalfunctionNov 30, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE MOZEC BALLOON WAS OPENED AND PASSED OFF TO THE SCRUB TECH AND WAS PREPPED AND PLACED ON THE WIRE. ONCE THE BALLOON WAS PLACED INTO THE BLOCKAGE AND INFLATED IT WOULDN'T HOLD PRESSURE. THE BALLOON WAS REMOVED AND THE SCRUB TECH NOTICED THERE WAS A HOLE IN THE SHAFT AND IT WAS LEAKING. AS REPORTED, AFTER THE 2.00 X 12 MOZEC BALLOON WAS PLACED INTO THE BLOCKAGE AND INFLATED, THE BALLOON WAS NOT ABLE TO HOLD THE PRESSURE. UPON REMOVAL OF THE BALLOON, A HOLE WAS NOTED IN THE SHAFT AND FROM WHERE THERE WAS A LEAKAGE. PATIENT WAS MALE, WEIGHING 200 POUNDS. THE TARGET LESION WAS OSTIAL MARGINAL WITH 90% STENOSIS AND THE VESSEL DIAMETER WAS 2.5 MM. THE LESION WAS MODERATELY CALCIFIED AND LITTLE TORTUOUS. THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED AS PER THE IFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NEITHER ANY DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP, NOR IN REMOVING THE PROTECTIVE COVER. THE DEVICE WAS PREPPED AS PER THE IFU DURING WHICH NO LEAKAGE WAS OBSERVED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8120620 ↗
• MalfunctionMay 1, 2018Sticking; Physical Resistance; Physical Property Issue; Sticking; Physical Resistance; Physical Property Issue

  PHYSICIAN WAS ATTEMPTING TO PRE DILATATE THE LEFT CIRCUMFLEX ARTERY. THE MOZEC 2.00X12 WAS LOADED ON A SHINOBI .014 WIRE AND INSERTED INTO THE LESION. AFTER PREDILATION, THE MOZEC WAS HUNG ON THE WIRE AND THE WIRE / BALLOON WERE REMOVED AS A UNIT. THE BALLOON IS STILL LOADED ON THAT WIRE. TO COMPLETE THE PROCEDURE THE PHYSICIAN REWIRED THE VESSEL AND INSERTED AN ABBOTT BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7477760 ↗