TAUT IPN006637Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704559787), received between Nov 10, 2023 and Nov 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K112456); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 10, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT "THE BALLOONS BURST. THE DEVICES HAVE A BALLOON TO UNABLE THE TROCAR TO MOVE DURING PROCEDURE. NEVERTHELESS, TWICE, THE BALLOON BURST, AND THE TROCAR MIGRATED OUTSIDE THE PATIENT DURING PROCEDURE. THEY WERE REPLACED BY A TROCAR FROM ANOTHER REFERENCE. THESE INCIDENTS CAUSED DELAY IN THE SURGERY, PROLONGING THE SURGERY TIME". ADDITIONAL INFORMATION STATES, "THE TROCAR COMPLETELY WENT OUT THE PATIENT IN BOTH CASES. ONE BALLOON COMPLETELY DEFLATED, THE OTHER WAS LEAKING. APART FROM THE LAPAROSCOPIC SCOPE, NO INSTRUMENTS HAD BEEN INSERTED THROUGH THE TROCAR." NO FURTHER INFORMATION IS AVAILABLE AS THE CUSTOMER STATED "AS THE EVENT TOOK PLACE TOO LONG AGO, SOME QUESTIONS REMAIN UNANSWERED AND THE ANSWERS ARE UNFORTUNATELY SOMETIMES IMPRECISE." IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDR #3003898360-2023-01537.

  Patient problems: Insufficient Information

  MAUDE report 18114313 ↗
• MalfunctionNov 10, 2023Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED THAT "THE BALLOONS BURST. THE BALLOON IS PIERCED AND CANNOT BE INFLATED AND THEREFORE THE DEVICE CANNOT BE USED. USE OF ANOTHER TROCAR FROM SAME REFERENCE AND SAME LOT. NO IMPACT ON THE STAFF OR THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112822 ↗
• MalfunctionNov 10, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT "THE BALLOONS BURST. THE DEVICES HAVE A BALLOON TO UNABLE THE TROCAR TO MOVE DURING PROCEDURE. NEVERTHELESS, TWICE, THE BALLOON BURST, AND THE TROCAR MIGRATED OUTSIDE THE PATIENT DURING PROCEDURE. THEY WERE REPLACED BY A TROCAR FROM ANOTHER REFERENCE. THESE INCIDENTS CAUSED DELAY IN THE SURGERY, PROLONGING THE SURGERY TIME". ADDITIONAL INFORMATION STATES, "THE TROCAR COMPLETELY WENT OUT THE PATIENT IN BOTH CASES. ONE BALLOON COMPLETELY DEFLATED, THE OTHER WAS LEAKING. APART FROM THE LAPAROSCOPIC SCOPE, NO INSTRUMENTS HAD BEEN INSERTED THROUGH THE TROCAR." NO FURTHER INFORMATION IS AVAILABLE AS THE CUSTOMER STATED "AS THE EVENT TOOK PLACE TOO LONG AGO, SOME QUESTIONS REMAIN UNANSWERED AND THE ANSWERS ARE UNFORTUNATELY SOMETIMES IMPRECISE." IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDR #3003898360-2023-01538.

  Patient problems: Insufficient Information

  MAUDE report 18111201 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112456. One submission often covers many models, so check the product and lot details in each record.

• Z-1289-2014 · Mar 11, 2014 · Terminated
  5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, an
• Z-1287-2014 · Mar 11, 2014 · Terminated
  5/10 Weck Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and all
• Z-1288-2014 · Mar 11, 2014 · Terminated
  5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allo
• Z-1328-2014 · Mar 11, 2014 · Terminated
  5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog N
• Z-1290-2014 · Mar 11, 2014 · Terminated
  5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and al
• Z-1286-2014 · Mar 11, 2014 · Terminated
  5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and