Extra ViewRecalls & reported problems across all models

We found 2 models of Extra View by Covidien LP in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and Aug 6, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Break” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Extra View problems

Extra View models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Extra View OMS-XB2

  Laparoscope, general & plastic surgery
  47 reports
• Extra View OMS-XB1

  Laparoscope, general & plastic surgery
  18 reports

Recent Extra View adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159062 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC HERNIA REPAIR, WHILE IN THE ABDOMEN, THE BALLOON DETACHED FROM THE HANDPIECE AND FELL INTO THE PATIENT¿S CAVITY. THE BALLOON WAS RETRIEVED LAPAROSCOPICALLY AND WAS FOUND TO BE INTACT.

  Patient problems: Insufficient Information

  MAUDE report 25361953 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST AND IT WAS IMPOSSIBLE TO INFLATE. THIS OCCURRED FOUR TIMES, REQUIRING THE USE OF FOUR ADDITIONAL DEVICES BEFORE ONE WORKED ON THE FIFTH ATTEMPT. A LOSS OF SURGICAL TIME WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338016 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST AND IT WAS IMPOSSIBLE TO INFLATE. THIS OCCURRED FOUR TIMES, REQUIRING THE USE OF FOUR ADDITIONAL DEVICES BEFORE ONE WORKED ON THE FIFTH ATTEMPT. A LOSS OF SURGICAL TIME WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338002 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST AND IT WAS IMPOSSIBLE TO INFLATE. THIS OCCURRED FOUR TIMES, REQUIRING THE USE OF FOUR ADDITIONAL DEVICES BEFORE ONE WORKED ON THE FIFTH ATTEMPT. A LOSS OF SURGICAL TIME WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337901 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, THE BALLOON PHYSICALLY BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838499 ↗
• MalfunctionNov 26, 2025Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, THE BALLOON DID NOT INSUFFLATE DURING THE DISSECTION OF THE SPACE. THE ISSUE WAS RESOLVED BY SWAPPING TO ANOTHER BALLOON TO COMPLETE THE CASE. THE BALLOON WAS INSPECTED, AND IT WAS CONFIRMED THAT THERE WAS A HOLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654985 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON PHYSICALLY BROKE WHEN THE BALLOON BURST AFTER 2-3 PUMPS. ANOTHER BALLOON WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22388256 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL EXTRAPERITONEAL (TEP) HERNIA REPAIR PROCEDURE, THE TROCAR BURST AFTER INSUFFLATION, AND THE BALLOON PHYSICALLY BROKE. THE ISSUE WAS RESOLVED BY REMOVING THE TROCAR SINCE THE ACTUAL PROCESS HAD BEEN COMPLETED. NO INJURY OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195200 ↗
• MalfunctionMay 29, 2025Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA PROCEDURE, ONE BALLOON MADE STRANGE NOISE AND DID NOT FULLY INFLATE. THE SURGEON STILL USED THE TROCAR DESPITE IT NOT BEING FULLY INFLATED. TWO OTHER BALLOONS THAT WERE ALSO USED PHYSICALLY BROKE AND DID NOT INFLATE. THE SURGEON JUST HAD TO USE BLUNT DISSECTION TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105921 ↗
• MalfunctionMay 29, 2025Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA PROCEDURE, ONE BALLOON MADE STRANGE NOISE AND DID NOT FULLY INFLATE. THE SURGEON STILL USED THE TROCAR DESPITE IT NOT BEING FULLY INFLATED. TWO OTHER BALLOONS THAT WERE ALSO USED PHYSICALLY BROKE AND DID NOT INFLATE. THE SURGEON JUST HAD TO USE BLUNT DISSECTION TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105822 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TEP (TOTALLY EXTRAPERITONEAL) INGUINAL PROCEDURE, THE BALLOON PHYSICALLY BROKE WHILE INFLATING THE BALLOON. THE ISSUE WAS RESOLVED BY USING BLUNT DISSECTION TO CREATE SPACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010886 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A HOLE IN THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884446 ↗
• MalfunctionMar 31, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BALLOON DID NOT EXPAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735067 ↗
• MalfunctionFeb 19, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA, THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413887 ↗

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