2cm Peripheral Cutting Balloon® M001PCB70201350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729813750), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE 75-80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, AT FIRST INFLATION, IT WAS NOTED THAT THE DEVICE BURST AT 4ATM WITHIN 7 SECONDS. THE DEVICE WAS REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455172 ↗