Occlusion Balloon Catheter M001171030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729112396), received between Mar 15, 2019 and Sep 21, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Inflation Problem

  Reportable based on device analysis completed on (b)(6)2026.It was reported that balloon expansion issue occurred.The target lesion was a tight stenotic occlusion located in the iliac artery. A 7/2/100 Occlusion Balloon Catheter was advanced for dilation. During the procedure, the balloon did not fully expand. The procedure was completed with a different device. There were no patient complications as a result of this event.However, device analysis revealed that the balloon ruptured.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844007 ↗
• MalfunctionDec 12, 2019Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE BECAME CONTAMINATED. A 7/2/100 OCCLUSION BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS CONTAMINATED AS IT FELL OFF ON THE TABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9459914 ↗
• MalfunctionMar 15, 2019Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS NOT PRESENT. THE TARGET LESION WAS LOCATED IN INTER ILIAC. A 7/2/100 OCCLUSION BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INSERTED THROUGH THE NON-BSC 7F INTRODUCER. HOWEVER, WHEN THEY INFLATED IT AND LIQUID FLUSHED OUT, IT WAS NOTED THAT THE BALLOON WAS NOT PRESENT ON THE CATHETER. NO FRAGMENTS OF THE DEVICE WERE FOUND, RECOVERED AND LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETE WITH DIFFERENT DEVICE. NO PROBLEM NOTED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424934 ↗