2cm Peripheral Cutting Balloon® M001PCB5020500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729813705), received between Apr 22, 2022 and Sep 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 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.

• MalfunctionSep 23, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. A 5.00MMX2.00CMX50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE IN THE LEFT ARM ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, THE BALLOON WOULD NOT HOLD PRESSURE UPON INFLATION AND A SMALL LEAK/HOLE IN THE BALLOON WAS NOTED UPON REMOVAL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469496 ↗
• MalfunctionApr 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BLADE WAS LIFTED. A 5.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CUTTING WIRE BROKE FREE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190632 ↗