OPN NC 350-015-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640142570608), received between May 21, 2025 and Dec 30, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Material Rupture; Material Rupture

  THE COMPLAINANT STATED THAT HE OPN BALLOON BROKE WHEN IT REACHED 22 ATMOSPHERES FOR APPROXIMATELY 15 SECONDS EVEN THOUGH IT IS MANUFACTURED TO WITHSTAND 34 ATMOSPHERES. THE COMPLAINANT REPORTS THAT THE PATIENT DIDN'T' HAVE A STENT, THAT THE EVENT DID NOT AFFECT THE PATIENT, AND THAT THE STENT WAS EVENTUALLY SUCCESSFULLY PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930997 ↗
• MalfunctionNov 5, 2025Break

  A BALLON WAS INSERTED OVER THE WIRE DURING A CORONARY INTERVENTION. THE PORTION OF THE BALLOON SHAFT THAT WAS OUTSIDE THE PATIENT'S BODY BROKE. THE BALLOON WAS REMOVED AND NOT USED. ALL PORTIONS OF THE BALLOON WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476430 ↗
• MalfunctionOct 27, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  THE REPORTER STATES THAT, "THE DEVICE WAS BEING USED IN THE NORMAL FASHION, AND THE SHAFT BROKE DURING THE INSERTION IN THE MIDDLE OF THE SHAFT. THE OTHER HALF WAS RETRIEVED AND THE PARTS TRASHED. THERE WERE NO KINKS OBSERVED PRIOR TO USE. THERE WAS NO IMPACT TO THE PATIENT WHEN THE BROKEN SHAFT. THEY USED ANOTHER MODALITY TO FINISH THE PROCEDURE..."

  Patient problems: Insufficient Information

  MAUDE report 23394025 ↗
• MalfunctionMay 21, 2025Material Rupture; Insufficient Device Problem Information; Material Rupture; Insufficient Device Problem Information

  THE CLINICIAN REPORTED VIA A DISTRIBUTOR THAT DURING DELIVERY THE SHAFT OF AN OPN NC BALLOON CATHETER "SNAPPED IN HALF" WHILE ADVANCING INTO THE PATIENT THROUGH THE GUIDING CATHETER. THERE WAS NO REPORTED IMPACT TO THE PATIENT AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Stenosis

  MAUDE report 22061494 ↗