TAUT IPN914249Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 14026704645227), received between Feb 2, 2022 and Mar 15, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Material Rupture; Material Rupture

  REPORTED ISSUE: THE BALLOON BURST DURING THE SECOND HALF OF THE OPERATION. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH THE DEVICE OF OTHER COMPANY TO COMPLETE THE PROCEDURE. NOTHING FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550887 ↗
• MalfunctionFeb 24, 2023Burst Container or Vessel; Burst Container or Vessel

  REPORTED ISSUE: DURING USE ON A PATIENT, THE BALLOON BURST. THE SURGEON RECOVERED ALL THE PARTS OF THE BALLOON FROM THE ABDOMEN.

  Patient problems: Insufficient Information

  MAUDE report 16437391 ↗
• MalfunctionJan 24, 2023Burst Container or Vessel; Burst Container or Vessel

  REPORTED EVENT: THE BALLOON GOT BURST DURING USE ON A PATIENT THEREFORE, THE DEVICE WAS REPLACED WITH A NEW ONE. NOTHING FELL/REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235706 ↗
• MalfunctionMay 10, 2022Break; Break

  THE BALLOON GOT BROKEN WHEN THE USER INSERTED THE TROCAR AND INFLATED THE BALLOON. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347930 ↗
• MalfunctionMay 6, 2022Burst Container or Vessel; Burst Container or Vessel

  THE BALLOON BURST WHEN THE USER INJECTED WATER INTO THE BALLOON AFTER INSERTING THE TROCAR INTO THE PATIENT. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW ONE. NOTHING FELL/REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14305171 ↗
• MalfunctionMay 5, 2022Break; Break

  THE BALLOON GOT BROKEN AND WATER LEAKED DURING A LAPAROSCOPIC NEPHRECTOMY. ALSO, THE TIP OF THE SYRINGE GOT BROKEN. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW ONE. NOTHING FELL/REMAINED IN THE PATIENT. ACCORDING TO THE USER, IT WAS UNKNOWN WHETHER THE BALLOON BROKE BECAUSE IT WAS TOUCHED BY SOME DEVICE OR BECAUSE IT WAS INITIALLY DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290003 ↗
• MalfunctionMar 29, 2022Break; Break

  THE BALLOON GOT BROKEN DURING A SURGERY. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW ONE. NOTHING FELL/REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939262 ↗
• MalfunctionFeb 15, 2022Break; Break

  THE DEVICE WAS USED WITH AN ENDOSCOPIC SCOPE (ELITE II 3D SCOPE, A FLEXIBLE SCOPE BY OLYMPUS) DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION. THE PROCEDURE WAS DONE WITHOUT PROBLEMS UNTIL WHEN REMOVING THE SCOPE, IT GOT STUCK WITH THE TROCAR AND COULD NOT BE PULLED OUT. WHEN THE USER TRIED TO PULL IT OUT FORCIBLY, THE BALLOON GOT BROKEN AND THE TROCAR AND THE CAMERA FELL OUT OF THE BODY CAVITY. THE SHAFT AND BALLOON CAME OFF. THE USER WOULD LIKE US TO CHECK THE DEVICE IF NO BROKEN PIECE WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535490 ↗
• MalfunctionFeb 2, 2022Burst Container or Vessel; Burst Container or Vessel

  SALINE WATER WAS FOUND LEAKING FROM THE BALLOON DURING A SURGERY. THEREFORE, THE USER REMOVED THE DEVICE AND REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION: WE RECEIVED THE MORE DETAILED INFORMATION FROM THE CUSTOMER VIA SALES REP: THE USER INSERTED THE DEVICE AND FIXED IT BY SALINE WATER IN A LAPAROSCOPIC SURGERY. WHEN INSERTING A 10MM CAMERA, HE/SHE FOUND SALINE WATER LEAKING FROM THE DEVICE. HE/SHE REMOVED IT AND FOUND THAT THE BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13427080 ↗

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-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
• 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