MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC25015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18906029358223), received between May 7, 2018 and Oct 16, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionOct 16, 2018Entrapment of Device; Entrapment of Device

  A 2.50 X 15 MOZEC¿ NC BALLOON WAS DIFFICULT TO REMOVE FROM A SION BLUE GUIDEWIRE AFTER POST DILATING A LESION. THE ARTERY INTERVENED WAS TORTUOUS. FIRST, A 2.50 X 15 MOZEC¿ NC WAS USED ON A WHISPER J WIRE AFTER ROTOBLADING. A 2.50 X 15 MOZEC¿ NC WAS THEN TAKEN UP TO 20 ATM. THE PHYSICIAN THEN SWITCHED TO A SION BLUE GUIDEWIRE, STENTED AND THEN POST DILATED WITH THE SAME MOZEC¿ NC WHICH WAS TAKEN UP TO 24 ATM. UPON REMOVING BALLOON FROM THE GUIDE CATHETER, HE NOTICED THAT IT BECAME DIFFICULT IN THE MID TO THIRD PART PROXIMAL OF THE GUIDEWIRE. A HEMOSTAT WAS THEN USED TO HELP HOLD THE GUIDEWIRE AND REMOVE THE BALLOON CATHETER. THE VESSEL WAS TORTUOUS. THERE WERE NO DIFFICULTIES IN REMOVING THE PRODUCT FROM THE HOOP. THERE WERE NO DIFFICULTIES IN REMOVING THE PROTECTIVE BALLOON COVER OR THE STYLET. THERE WERE NO DIFFICULTIES IN REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO PATIENT. THE DEVICE WAS STORED AND PREPARED AS PER THE IFU. THERE WAS NO DEVICE KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970098 ↗
• InjuryAug 29, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, AFTER OPENING THE BLOCKAGE AND DEFLATING THE BALLOON, RESISTANCE WAS FELT DURING REMOVAL OF THE MOZECTM BALLOON CATHETER (NC RX PTCA 2.5.00 MM X 30 MM). THE DOCTOR FELT THE BALLOON CATHETER JUMP BACK AND, AFTER REMOVAL, FOUND THAT THE DEVICE CAME APART AT THE RX PORT AND THE DISTAL PART OF THE BALLOON WAS STILL IN THE PATIENT. THE DOCTOR ATTEMPTED REMOVAL USING A NON-CORDIS DEVICE UNSUCCESSFULLY. THE DOCTOR ENDED UP TRAPPING THE SEPARATED PIECE USING AN UNKNOWN BALLOON AND WAS ABLE TO REMOVE THE SEPARATED SECTION. THE PROCEDURE STARTED AS A TOTAL HEART CATHETERIZATION BUT TURNED INTO AN INTERVENTION TO THE DISTAL RIGHT CORONARY ARTERY (RCA). THE RCA WAS DESCRIBED AS HEAVILY CALCIFIED AND TORTUOUS. THE TARGET ARTERY WAS INITIALLY ACCESSED USING A NON-CORDIS GUIDE CATHETER, A NON-CORDIS GUIDEWIRE AND A NON-CORDIS GUIDE EXTENSION. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH SIX ELUNIR STENTS BEING IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS NOT RESTERILIZED. NO ANOMALIES WERE NOTED WHEN REMOVED FROM THE PACKAGE. NO ANOMALIES WERE NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7829221 ↗
• MalfunctionMay 7, 2018Sticking; Device Issue; Physical Resistance; Physical Property Issue; Sticking; Device Issue; Physical Resistance; Physical Property Issue

  THE MOZEC 2.5 X 15 MM NC WAS USED TO POST DILATE WHILE ON ASAHI 0.014" FIELDER XT-A WIRE. THE BALLOON WAS INFLATED TO 20 RBP AND IT APPEARED TO BE WORKING WELL. AFTER DEFLATING MOZEC BALLOON, FELLOW DR. (B)(6) NOTICED IT WAS SLIGHTLY DIFFICULT TO MOVE BACK. WAS ABLE TO GET BALLOON AND WIRE BACK INTO GUIDE CATHETER. THEN, HAD TO CLAMP THE WIRE TO GET MOZEC NC BALLOON OFF OF THE ASAHI FIELDER XT-A WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491074 ↗