Vaginal CT/MR Multi Channel Applicator 110750-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717213022416), received between Feb 28, 2019 and Feb 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2019Use of Device Problem; Material Perforation; Device Dislodged or Dislocated; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE VAGINAL TUBE FOR THE 25, 30 AND 25 MM SET WILL NOT STAY LOCKED IN PLACE. UNFORTUNATELY A PATIENT'S VAGINAL CUFF WAS PERFORATED WHEN THE VAGINAL TUBE BECAME DISLODGED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8377997 ↗