TAUT IPN006635Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704559756), received between May 16, 2023 and May 19, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 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.

• InjuryMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "DURING ROBOT-ASSISTED SURGERY, A PIECE OF THE BALLOON WAS FOUND DETACHED FROM THE TROCAR IN THE PATIENT'S ABDOMEN. UNSUCCESSFUL EXTRACTION ATTEMPT, GIVEN THE SIZE OF THE DETACHED PIECE. IN THE END, FOREIGN BODY FOUND TRAPPED IN ANOTHER TROCAR. CONSEQUENCES: LONGER OPERATING TIME - LAPAROSCOPIC SEARCH FOR THE PIECE". ADDITIONAL INFORMATION RECEIVED STATES THAT "IT TOOK 1 HOUR TO RECOVER ALL THE PARTS FROM THE BALLOON OUT OF THE PATIENT. PATIENT IS FINE. ALL THE PIECES WERE RECOVERED, BUT WITH A DIFFERENT TROCAR".

  Patient problems: Insufficient Information

  MAUDE report 22046593 ↗
• MalfunctionMay 16, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING USE AT THE BEGINNING OF THE PROCEDURE, THE BALLOON BURST. AS A RESULT, A 2ND BALLOON WAS USED WHICH BURST AS WELL. A 3RD BALLOON WAS USED WITH NO ISSUES. AN X-RAY WAS USED TO VISUALIZE THE BROKEN PIECES, ALL WERE REMOVED FROM THE PATIENT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR 3003898360-2023-00729.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940915 ↗
• MalfunctionMay 16, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING USE AT THE BEGINNING OF THE PROCEDURE, THE BALLOON BURST. AS A RESULT, A 2ND BALLOON WAS USED WHICH BURST AS WELL. A 3RD BALLOON WAS USED WITH NO ISSUES. AN X-RAY WAS USED TO VISUALIZE THE BROKEN PIECES, ALL WERE REMOVED FROM THE PATIENT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR 3003898360-2023-00728.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940889 ↗