2cm Peripheral Cutting Balloon® M001PCB8020500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729813798), received between May 7, 2021 and Jul 24, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• InjuryJul 24, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED, REQUIRING THE USE OF A NEEDLE TO DEFLATE IT. AN 8.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO LESS THAN 10 ATMOSPHERES; HOWEVER, THE BALLOON WOULD NOT DEFLATE DURING THE ATTEMPT TO DEFLATE IT. MULTIPLE ATTEMPTS WERE MADE, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN HAD TO PLACE A SMALL NEEDLE THROUGH THE PATIENT'S SKIN TO PUNCTURE THE BALLOON IN THE PATIENT'S ARM. A FISTULA WAS BEING TREATED IN THE ARM AND THE VESSEL IS REALLY SUPERFICIAL SO PLACING A NEEDLE IS A VERY EASY PROCESS TO GET TO THE BALLOON. IT TOOK 5 MINUTES TO DEFLATE THE BALLOON. THE BALLOON WAS FULLY DEFLATED AND REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588608 ↗
• MalfunctionJan 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BLADE DETACHMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS ARTERIOVENOUS FISTULA. AN 8.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, A 7FR NON-BOSTON SCIENTIFIC SHEATH WAS PLACED IN THE VESSEL AND A 0.35 MUSTANG BALLOON CATHETER WAS USED FIRST. SUBSEQUENTLY, ANGIOGRAPHY SHOWS RESIDUAL STENOSIS, SO A CUTTING BALLOON WAS NEEDED. THE PCB DEVICE WAS OPENED AND LOADED ONTO A V-18 GUIDEWIRE ACROSS THE LESION AND THEN INFLATED TO NOMINAL PRESSURE. THE DEVICE WAS THEN REMOVED AND FOUND THE METAL CUTTERS WERE COMING OFF THE BALLOON. ALL THE METAL CUTTING PIECES OF THE BALLOON WERE ACCOUNTED FOR AND NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484123 ↗
• MalfunctionNov 29, 2023Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN 8.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE BALLOON WAS REMOVED AND UPON TRYING TO INFLATE, A LEAK AND A TINY HOLE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230711 ↗
• MalfunctionMay 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 80-85% STENOSED TARGET LESION AREA WAS LOCATED IN THE CEPHALIC VEIN CONFLUENCE. AN 8.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 6 ATMOSPHERES FOR 30 SECONDS, HOWEVER IT DID NOT INFLATE UPON ATTEMPTING TO INFLATE IT AGAIN IN ANOTHER PART OF THE STENOSIS. SUBSEQUENTLY, THE BALLOON RUPTURED AND THERE WAS BLOOD MIXED IN THE BARREL WHEN THE PLUNGER WAS PULLED BACK. THE BALLOON WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE BUT SAME INDEFLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791637 ↗