WECK IPN914269Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704645210), received between Jun 9, 2022 and Dec 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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.

• MalfunctionDec 30, 2022Burst Container or Vessel; Burst Container or Vessel

  REPORTED ISSUE: THE BALLOON BURST DURING THE ROBOT ASSISTED RADICAL PROSTATECTOMY. 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 16079292 ↗
• MalfunctionNov 23, 2022Break; Break

  IT WAS REPORTED THAT THE BALLOON WAS BROKEN DURING A ROBOT-ASSISTED TOTAL PROSTATECTOMY, USING A CAMERA PORT. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW UNIT. ACCORDING TO THE USER, THERE WAS ALMOST NO POSSIBILITY THAT THE BALLOON FRAGMENTS REMAINED IN THE BODY BUT WOULD LIKE US TO CONFIRM THE DEVICE INCLUDING CONFIRMATION OF THE APPEARANCE OF THE DEVICE. ALSO, ACCORDING TO THE USER, HE/SHE MIGHT HAVE HURT THE TOP OF THE BALLOON WHEN INSERTING A NEEDLE INTO THE SKIN LAYER AFTER A SMALL INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853886 ↗
• MalfunctionJun 9, 2022Break; Break

  AFTER AN INFLATION TEST OF THE BALLOON BY 10ML OF SALINE WATER, THE DEVICE WAS INSERTED INTO THE ABDOMINAL CAVITY. INFLATION OF THE BALLOON WAS CONFIRMED BY A PORT CAMERA. HOWEVER, WHEN REMOVING THE DEVICE AT THE END OF THE SURGERY, THE BALLOON WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14647288 ↗

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-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-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
• 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-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