AMSORB® PLUS AMAB3801GERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060505643701), received between Dec 16, 2021 and Mar 20, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionMar 20, 2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648166 ↗
• MalfunctionDec 16, 2021Crack; Fracture

  ANOTHER FAILURE WITH THE SODA LIME CANISTER FRACTURING. TEAM WAS UNABLE TO VENTILATE THE PATIENT ON THE GAS MACHINE AND HAD TO EMERGENTLY AMBU THE PATIENT UNTIL A NEW SODA LIME CANISTER WAS FOUND. TEAM COMPLAINING NUMEROUS ISSUES WITH CRACKED CANISTERS. UNFORTUNATELY, THE FRACTURED CANISTER WAS NOT SAVED NOR WERE PHOTOGRAPHS TAKEN. THE PATIENT DID NOT HAVE AN ADVERSE OUTCOME BECAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017632 ↗
• MalfunctionDec 16, 2021Break; Physical Resistance/Sticking

  DURING A SURGICAL PROCEDURE, THE PATIENT'S CTCO2 LEVELS HAD BEEN RISING SO IT WAS DECIDED TO CHANGE OUT THE ABSORBER CANISTER. WHEN THE NEW CANISTER WAS IN THE CRADLE AND PLACED INTO THE UPRIGHT POSITION, A LARGE PIECE OF PLASTIC FROM THE CANISTER FLEW OFF. THE CANISTER BECAME JAMMED IN A NON-FUNCTIONAL POSITION. THE TEAM WAS NOT ABLE TO VENTILATE THE PATIENT AND THERE WAS NO AMBU-BAG IN THE ROOM. THE TEAM FINALLY GOT THE EQUIPMENT UNJAMMED AND PUT THE OLD CANISTER IN THE MACHINE. FORTUNATELY, THE PATIENT'S OXYGEN SATURATIONS NEVER DROPPED. THE FAILURE WAS DISCUSSED BY THE OR TEAM AND THE BROKEN ABSORBER CANISTER WAS SAVED. DURING THE DISCUSSION OF THE EVENT, ANOTHER TEAM MEMBER REPORTED THAT THEY HAD HEARD OF SEVERAL SIMILAR INCIDENTS (AT LEAST TWO, POSSIBLY FOUR) OF ABSORBER CANISTERS BREAKING IN THE ANESTHESIA MACHINE. HOWEVER, THIS IS THE ONLY ONE THAT WAS DOCUMENTED IN AN EVENT REPORT. THE MANUFACTURE'S REPRESENTATIVE WAS NOTIFIED AND WILL BE FOLLOWING UP WITH ANESTHESIA TEAM MEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017630 ↗