GUARDIANRecalls & reported problems across all models
Cardinal Health 200, LLC · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 2
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of GUARDIAN by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2018 and Mar 14, 2024 — classified as 2 deaths, 3 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (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. 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
Reports received per month, all models
Most reported GUARDIAN problems
Device problems
- Suction Failure11
- Break8
- Appropriate Device Problem Term/Code Not Available3
- Suction Problem3
- Fitting Problem2
- Adverse Event Without Identified Device or Use Problem1
- Aspiration Issue1
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Hemorrhage/Blood Loss/Bleeding2
- No Known Impact Or Consequence To Patient2
- Pain2
- Vomiting2
- Death1
- Exposure to Body Fluids1
- Insufficient Information1
GUARDIAN models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GUARDIAN 65651-212APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 deaths12 reports
- GUARDIAN 65651-220APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED3 reports
- GUARDIAN 65651-230APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED3 reports
- GUARDIAN 65651-120APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 reports
Recent GUARDIAN adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJan 5, 2022Burst Container or Vessel; Suction Failure; Burst Container or Vessel; Suction Failure
CUSTOMER REPORTED THE PROCEDURE WAS A PLANNED AIRWAY SUCTIONING. THE CANNISTER WITH SMALL AMOUNTS OF ORAL SECRETIONS SHATTERED IN MULTIPLE LOCATIONS AFTER COMPLETING ROUTINE SUCTIONING OF THE PATIENT. THERE WAS A LOUD BANG HEARD WHEN THE CANISTER BROKE. THE SUCTION CANISTER WAS CONTAMINATED WITH ORAL SECRETIONS WHEN THE PRODUCT LOST ITS SUCTION CAPABILITY. THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT BUT THERE WAS BODILY FLUID EXPOSURE AS A PORTION OF THE CONTAINER DID CONTACT THE INTACT SKIN OF THE PRIMARY RN. THERE WERE NO ADVERSE EFFECTS TO RN. AT PRESENT RN IS DOING FINE.
Patient problems: Exposure to Body Fluids
MAUDE report 13172737 ↗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 ↗MalfunctionJun 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE SUCTION CANISTER IMPLODED DURING SURGERY. THE PHYSICIAN WAS HIT IN THE BACK WITH A LARGE PIECE OF CANISTER, BUT WAS NOT HURT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7645612 ↗MalfunctionJun 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE SUCTION CANISTER IMPLODED DURING SURGERY, AND FLUID SPLASHED IN THE TECH¿S EYE. HER EYE WAS FLUSHED WITH WATER AND SHE WAS REFERRED TO EMPLOYEE HEALTH FOR BLOOD EXPOSURE WORK UP INCLUDING TESTING FOR BLOOD BORNE PATHOGEN TESTING. APPARENTLY THE PATIENT WAS (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7645601 ↗
Other Cardinal Health 200, LLC products
- JACKSON-PRATT20 models · 13 reports · 19 recalls
- Monoject35 models · 96 reports · 11 recalls
- CONVERTORS38 models · 40 reports · 11 recalls
- Argyle33 models · 58 reports · 7 recalls
- Salem Sump31 models · 40 reports · 7 recalls
- Dover45 models · 241 reports · 2 recalls
- Kendall31 models · 51 reports · 3 recalls
- Kangaroo35 models · 130 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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