NA 601296Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964325823), received between Dec 28, 2016 and Dec 11, 2018 — classified as 3 malfunctions.

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

• MalfunctionDec 11, 2018Activation Failure; Activation Failure

  AS REPORTED BY THE USER FACILITY: AFTER THE BALLOON CATHETER WAS IMPLANTED, IT FAILED TO INFLATE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8150989 ↗
• MalfunctionMar 30, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  AS REPORTED BY THE USER FACILITY: CATHETER BALLOON UNABLE TO INITIATE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6446129 ↗
• MalfunctionDec 28, 2016Deflation Problem; Deflation Problem

  AS REPORTED BY USER FACILITY: BALLOON CATHETER WAS INSERTED TO OBTAIN A CS VENOGRAM. THE BALLOON CANNOT BE DEFLATED. THE PHYSICIAN DECIDED TO INJECT MORE AIR TO THE BALLOON CATHETER AND THE BALLOON RUPTURED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6208715 ↗