Extra View OMS-XB1Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521068025), received between May 21, 2018 and Aug 6, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 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, 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 18 most recent of 18 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 14, 2024Break; Break

  ACCORDING TO THE REPORTER, WHILE INFLATING, THE THREE BALLOONS POPPED.

  Patient problems: Insufficient Information

  MAUDE report 19987180 ↗
• MalfunctionAug 14, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, WHILE INFLATING, THE THREE BALLOONS POPPED.

  Patient problems: Insufficient Information

  MAUDE report 19987169 ↗
• MalfunctionAug 14, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, WHILE INFLATING, THE THREE BALLOONS POPPED.

  Patient problems: Insufficient Information

  MAUDE report 19987160 ↗
• MalfunctionAug 14, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TEP (TOTALLY EXTRAPERITONEAL) HERNIA REPAIR PROCEDURE, AT THE TIME OF INFLATING THE BALLOON TO CREATE THE PREPERITONEAL SPACE, THE DEVICE POPPED WHICH LED TO BLEEDING. THE SURGEON CONTINUED THE PROCEDURE, BUT THERE WAS A LOT OF BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19981395 ↗
• MalfunctionAug 14, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, WHILE IN THE EXTRAPERITONEAL SPACE, THE BALLOON POPPED WHILE BEING INFLATED. THE CASE WAS CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19979912 ↗
• MalfunctionAug 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL (TEP) INGUINAL HERNIA REPAIR, IN THE EXTRAPERITONEAL SPACE, THE BALLOON POPPED DURING INFLATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973563 ↗
• MalfunctionApr 15, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL INGUINAL HERNIA REPAIR, WHEN CREATING A PRE-PERITONEAL SPACE, THE BALLOON DID NOT INFLATE AND HAD A LEAKED GAS/AIR. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM AS A BLUNT DISSECTION HAD TO BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106138 ↗
• MalfunctionOct 5, 2023Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE BALLOON DID NOT INFLATE. THE ISSUE OCCURRED IN TWO BAL LOONS. A THIRD BALLOON WITH A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. AFTER THE PROCEDURE, THE DEVICES WERE TESTED IN THE BACK TABLE, BUT THE ISSUE REMAINED THE SAME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17883117 ↗
• MalfunctionOct 5, 2023Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A DURING LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE BALLOON DID NOT INFLATE. THE ISSUE OCCURRED IN TWO BALLOONS. A THIRD BALLOON WITH A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. AFTER THE PROCEDURE, THE DEVICES WERE TESTED IN THE BACK TABLE, BUT THE ISSUE REMAINED THE SAME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17883116 ↗
• MalfunctionApr 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING THE DISSECTION PERIOD, THE BALLOON POPPED ONE AFTER THE OTHER. A NEW SPACEMAKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675316 ↗
• MalfunctionApr 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING THE DISSECTION PERIOD, THE BALLOON POPPED ONE AFTER THE OTHER. A NEW SPACEMAKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675310 ↗
• MalfunctionApr 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING THE DISSECTION PERIOD, THE BALLOON POPPED ONE AFTER THE OTHER. A NEW SPACEMAKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675276 ↗
• MalfunctionFeb 27, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROSTATECTOMY, THE BALLOON BURST WHILE MAKING OF SPACE IN CAVITY. FRAGMENTS OF THE BALLOON WERE IN THE PATIENT'S CAVITY. SURGEONS WERE ABLE TO REMOVE THE FRAGMENTS THAT WERE RETRIEVED USING GRASPER.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9762650 ↗
• MalfunctionMay 21, 2018Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE TROCAR BROKE AND A PIECE DISENGAGED INTO THE PATIENT'S CAVITY BUT WAS RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531226 ↗