TAUT IPN006689Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04026704559763), received between Jun 6, 2023 and Feb 26, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K121796); 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT "DURING A COELIO SURRENALECTOMY, WHEN THE OPEN BALLOON TROCAR WAS INSERTED IT DEFLATED AND DID NOT REMAIN IN PLACE. THERE WAS A RISK OF ORGAN OR TISSUE DAMAGE AND THERE WAS A POOR VISUALIZATION OF THE OPERATING FIELD". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21470061 ↗
• MalfunctionMay 16, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "DURING A LAPAROSCOPY, THE TEAM DISCOVERED THAT 3 WECK VISTA TROCARS HAD HOLES IN THE BALLOONS, AND THEY HAD TO USE SEVERAL OF THEM FOR THE SURGERY". NO PATIENT'S INJURY OR CONSEQUENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330755 ↗
• MalfunctionMay 16, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "DURING A LAPAROSCOPY, THE TEAM DISCOVERED THAT 3 WECK VISTA TROCARS HAD HOLES IN THE BALLOONS, AND THEY HAD TO USE SEVERAL OF THEM FOR THE SURGERY". NO PATIENT'S INJURY OR CONSEQUENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330687 ↗
• MalfunctionMay 16, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "DURING A LAPAROSCOPY, THE TEAM DISCOVERED THAT 3 WECK VISTA TROCARS HAD HOLES IN THE BALLOONS, AND THEY HAD TO USE SEVERAL OF THEM FOR THE SURGERY". NO PATIENT'S INJURY OR CONSEQUENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330262 ↗
• MalfunctionNov 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THE BALLOON GOT BURST DURING A UROLOGICAL SURGERY. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NOTHING FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT WAS REPORTED". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169533 ↗
• MalfunctionNov 20, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT "THE BALLOON GOT BURST DURING A UROLOGICAL SURGERY. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NOTHING FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT WAS REPORTED". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169495 ↗
• MalfunctionJun 6, 2023Disconnection; Disconnection

  IT IS REPORTED THAT WHILE IN USE ON A LONG-TERM VENTILATED PATIENT, "THE CATHETER MOUNT USED TO BE ABLE TO MANUAL HYPERINFLATE THE LUNGS WITH A WATER'S TYPE CIRCUIT DOES NOT FIT ON PROPERLY SO FLIES OFF DURING TREATMENT. THE PASSY MUIR SPEAKING VALVES USED DURING VENTILATOR FREE BREATHING DO NOT FIT ON CORRECTLY AND FALL OFF, AND THE SAME CATHETER MOUNTS THAT CONNECT TO THE VENTILATOR DO NOT FIT ON WELL EITHER AND WE NEED TO USE OTHER MEASURES TO FIX IT". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17070261 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121796. One submission often covers many models, so check the product and lot details in each record.

• Z-1277-2014 · Mar 11, 2014 · Terminated
  10mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipula
• Z-1282-2014 · Mar 11, 2014 · Terminated
  12mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipula
• Z-1324-2014 · Mar 11, 2014 · Terminated
  10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination