MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC30013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18906029358377), received between Dec 11, 2018 and Mar 9, 2020 — classified as 2 malfunctions.

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

• MalfunctionMar 9, 2020Material Deformation; Material Deformation

  AS REPORTED, A 3.00 X 13 MM MOZECTM NC - RX PTCA BALLOON DILATATION CATHETER WAS USED FOR A POST DILATION OF A STENT. IT DID NOT POST DILATE THE DEPLOYED ONYX STENT. THE BLUE PART OF THE SHAFT LOOKS WITH DEFECT. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS USED FOR THE MALE TO POST DILATE A STENT. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY IN REMOVING THE PROTECTIVE BALLOON COVER OR THE STYLET. THERE WERE NO ANOMALIES NOTED TO THE DEVICE PRIOR TO USE. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THE DEVICE WAS PREPPED PER THE IFU. THERE WERE NO KINKS OR OTHER DAMAGES NOTED TO THE DEVICE PRIOR TO INSERTING INTO THE PATIENT. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HAEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. THERE WAS NO UNUSUAL FORCE USED DURING THE LOADING ON THE GUIDE WIRE. THERE WAS NO RESISTANCE OR ABNORMAL DEVICE INTERACTION NOTICED DURING ADVANCEMENT. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO RESISTANCE OR ABNORMAL DEVICE INTERACTION NOTICED DURING LESI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9804182 ↗
• MalfunctionDec 11, 2018Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A 3.0X13 MOZEE NC WAS DIFFICULT TO REMOVE FROM SION BLUE WIRE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS STORED AND HANDLED AS PER THE IFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE AND THE DEVICE WAS REMOVED FROM THE PACKAGE WITHOUT ENCOUNTERING ANY DIFFICULTY. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP AND IN REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS NORMALLY PREPPED FOLLOWING THE IFU WITHOUT USING ANY EXCESS FORCE. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. NO ANOMALIES WERE NOTED DURING OR AFTER THE DEVICE WAS PREPPED. NO VISIBLE SIGNS OF KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. NO RESISTANCE I FRICTION WAS EXPERIENCED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND WHILE CROSSING THE TARGET LESION. NO VISIBLE SIGNS OF KINK OR DAMAGE WERE NOTED ANYTIME DURING THE PROCEDURE AND NO UNUSUAL FORCE WAS APPLIED ANYTIME DURING THE PROCEDURE. THERE WAS NO DIFFICULTY ENCOUNTERED WHEN CONNECTING THE HUB TO THE INDEFLATOR AND THE DEVICE WAS NOT ADVANCED WITH THE INDEFLATOR CONNECTED TO THE HUB. THE BALLOON WAS INFLATED NORMALLY A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150942 ↗