2cm Peripheral Cutting Balloon® M001PCB5020900Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729813712), received between Mar 2, 2020 and Mar 14, 2022 — classified as 2 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 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.

• MalfunctionMar 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5MM X 2.0CM X 90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURE AT 4ATM. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VENOUS ANASTOMOSIS AT THE ELBOW REGION. DURING AT FIRST INFLATION, THE BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13764695 ↗
• MalfunctionMar 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE IN-STENT RESTENOSED LEFT RENAL ARTERY. A 5.00MMX2.0CMX90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, AT SECOND INFLATION, IT WAS NOTED THAT THE BALLOON RUPTURED AT 6ATM FOR 30 SECONDS. THE BALLOON WAS REMOVED SAFELY FROM THE PATIENT THROUGH THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775590 ↗