GUARDIAN 65651-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 50630140152533), received between Jul 31, 2018 and Mar 14, 2024 — classified as 2 deaths, 10 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED WITH QUESTIONS ABOUT MEDIVAC GUARDIAN 1200CC CANISTER. THEY HAD AN INCIDENT WITH USE WHERE SUCTION WAS LOST WHILE USING, AND A PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 18908673 ↗
• MalfunctionApr 25, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197526 ↗
• MalfunctionApr 25, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197515 ↗
• MalfunctionApr 25, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197494 ↗
• MalfunctionApr 25, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197430 ↗
• MalfunctionApr 25, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197411 ↗
• MalfunctionApr 25, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197410 ↗
• MalfunctionApr 25, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197350 ↗
• MalfunctionApr 23, 2022Break; Suction Failure; Suction Failure

  CUSTOMER REPORTED THEY RECEIVED TWO CASES OF SUCTION CANISTERS WHERE THE BOXES WERE DAMAGED UPON BREAKING DOWN THEIR PALLET. THEY WERE NOT NOTICED AS THE BOXES WERE IN THE MIDDLE. THE PRODUCT LOOKED USABLE BUT ON MULTIPLE OCCASIONS THEY STOPPED WORKING MID PROCEDURE DURING VARIOUS PLANNED GASTROINTESTINAL PROCEDURES. THERE WAS A 1-2 MINUTE DELAY TO SWITCH OUT THE CANISTERS. EVENT DATE IS UNKNOWN. NO DEMOGRAPHICS WERE PROVIDED. NO INJURY TO PATIENT. PATIENT REPORTED DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191021 ↗
• MalfunctionApr 6, 2022Suction Failure; Suction Failure

  CUSTOMER REPORTED THAT BLUE TOP SUCTION CANISTER WAS NOT HOLDING SUCTION WHEN USED WITH AN NG TUBE. THERE WAS NO DELAY IN PROCEDURE AND NO INJURY. THE EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021536 ↗
• MalfunctionMar 22, 2022Suction Failure

  CUSTOMER REPORTED THE BLUE TOP SUCTION CANISTERS ARE NOT HOLDING SUCTION DURING EMERGENCY NG TUBE PROCEDURE. REPORTEDLY, ANOTHER CANISTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY OR PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847226 ↗
• DeathJul 31, 2018Suction Problem

  WHILE WORKING ON A PATIENT, STAFF REPORTS THAT THE SUCTION WAS WORKING, THEN STOPPED. THE PATIENT DID PASS AWAY, BUT HOSPITAL HAS REPORTED THAT THEY BELIEVE THE PATIENT DEATH WAS NOT AS A RESULT OF THE SUCTION CANISTER. IT DID DELAY SUCTIONING IN THE MOUTH OF THE PATIENT AFTER INTUBATION, BUT HOSPITAL HAS REPORTED PATIENT CODED A SECOND TIME AT A LATER TIME.

  Patient problems: Death

  MAUDE report 7737095 ↗