Small Peripheral Cutting Balloon® M001PCBO3515140F0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729819752), received between Sep 30, 2020 and Sep 30, 2020 — 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 16, 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 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 9% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HIGHLY CALCIFIED TIBIAL ARTERY. A 3.50MM/ 1.5CM/ 140CM AND A 3.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOONS RUPTURED AND WERE REMOVED NORMALLY OFF THE WIRE. A 4 X 100 STERLING BALLOON CATHETER WAS USED AND COMPLETED THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10606739 ↗