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MozecTM Rx PTCA Balloon Dilatation Catheter MOZ25009Recalls & reported problems

Meril Life Sciences Private Limited · MozecTM Rx PTCA Balloon Dilatation Catheter, 2.50 mm x 09 mm, Rapid Exchange · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18904224907697), received between Nov 21, 2017 and Nov 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Device problems

  • Patient-Device Incompatibility2
  • Device Issue1
  • Device Operational Issue1
  • Difficult to Advance1
  • Failure to Advance1
  • Mechanical Problem1
  • Positioning Problem1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 28, 2017Mechanical Problem; Failure to Advance; Patient-Device Incompatibility; Positioning Problem; Mechanical Problem; Failure to Advance; Patient-Device Incompatibility; Positioning Problem

    BALLOON WAS UNABLE TO CROSS. PATIENT HAD VERY TORTUOUS VESSELS. DR. PARK STARTED RADIALLY AND HAD TO SWITCH TO GROIN DUE TO TORTUOUS VESSELS. HE TRIED TO CROSS WITH A MOZEC 2.5X09 BALLOON. HE ENDED UP USING A COMPETITOR OVER THE WIRE BALLOON OF SAME SIZE JUST TO GET EXTRA PUSHABILITY TO GET ACROSS LESION (HE NEVER INFLATED THAT BALLOON), THEN HE USED A LARGER SIZEN MOZEC3.0X09 BALLOON AND WAS ABLE TO GET ACROSS LESION AND PRE-DILATE PRIOR TO STENTING. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7064464 ↗
  • MalfunctionNov 21, 2017Device Issue; Patient-Device Incompatibility; Device Operational Issue; Difficult to Advance; Device Issue; Patient-Device Incompatibility; Device Operational Issue; Difficult to Advance

    BALLOON WAS UNABLE TO CROSS LESION. THEY USED A COMPETITOR BALLOON OF A LITTLE SMALLER DIAMETER AND IT WAS ABLE TO CROSS LESION. NO INJURY TO PATIENT AND THE PATIENT IS REPORTED TO BE DOING WELL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7048999 ↗

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Sources and updates

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