Medisorb™ M1173311Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10190752184336), received between Aug 11, 2023 and Jul 3, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Gas/Air Leak; Gas/Air Leak

  SUN MED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT UNITS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3010838917-2024-00202 FOR THE FIRST REPORT. REFER TO 3010838917-2024-00204 FOR THE THIRD REPORT. IT WAS REPORTED, [IT WAS OBSERVED] LEAKING AND FAILURE OF THE PRODUCT TO REMOVE CARBON DIOXIDE (CO2) FROM THE CIRCUIT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 20JUN2024 REPORTED, THE FICO2 READ 5; THE CANISTER WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19672013 ↗
• MalfunctionJul 3, 2024Gas/Air Leak; Gas/Air Leak

  SUN MED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT UNITS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3010838917-2024-00203 FOR THE SECOND REPORT. REFER TO 3010838917-2024-00204 FOR THE THIRD REPORT. IT WAS REPORTED, [IT WAS OBSERVED] LEAKING AND FAILURE OF THE PRODUCT TO REMOVE CARBON DIOXIDE (CO2) FROM THE CIRCUIT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 20JUN2024 REPORTED, THE CARBON DIOXIDE (ETCO2) WAS AROUND 40; A NEW CANISTER WAS PLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19672012 ↗
• MalfunctionAug 11, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE M1173311 - MULTI ABSORBER EF, DISPOSABLE WAS NOT ABSORBING ANY CO2. THE REPORTED ISSUE HAPPENED DURING PATIENT USE; UNKNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 17506911 ↗