2cm Peripheral Cutting Balloon® M001PCB6020500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729813736), received between Aug 9, 2019 and Jul 30, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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.

• MalfunctionJul 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INFLATION AT 6-8 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860126 ↗
• MalfunctionSep 10, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE SHAFT RIPPED IN HALF. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 6.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE CATHETER SHAFT WAS KINKED AND WOULD NOT PASS THE WIRE. DURING REMOVAL OF THE WIRE, IT WAS NOTED THAT THE SHAFT RIPPED IN HALF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10516291 ↗
• MalfunctionAug 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT FOREARM VESSEL. A 6.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED BELOW NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891309 ↗
• MalfunctionAug 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 75% STENOSED TARGET LESION WAS LOCATED IN LEFT CEPHALIC VEIN. A 6.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, AT INFLATION, IT WAS NOTED THAT THE BALLOON RUPTURED BELOW NOMINAL PRESSURE A 6 ATMOSPHERE IN LESS 10 SECONDS. THERE WERE NO BEND IN THE VESSEL. THE DEVICE WAS REMOVED FROM THE PATIENT BODY DIFFICULTY THROUGH THE SHEATH THAT WAS PLACED INITIALLY ARTERIOVENOUS (AV) FISTULA VEIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME BSC BALLOON DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880858 ↗