MEDI-VACRecalls & reported problems across all models
Cardinal Health 200, LLC · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of MEDI-VAC by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Apr 14, 2017 and Nov 24, 2021 — classified as 2 deaths, 1 injury, 20 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
Most reported MEDI-VAC problems
Device problems
- Suction Failure11
- Crack8
- Break4
- Decrease in Suction4
- Suction Problem4
- Leak/Splash3
- Detachment Of Device Component1
- Device Inoperable1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Death2
- Insufficient Information2
- Aspiration/Inhalation1
- Cardiac Arrest1
- Exposure to Body Fluids1
- No Known Impact Or Consequence To Patient1
MEDI-VAC models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MEDI-VAC 65652-616APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED15 reports
- MEDI-VAC 65652-611APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 death4 reports
- MEDI-VAC 65652-511APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- MEDI-VAC 65651-920GAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- MEDI-VAC 65652-616AAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- MEDI-VAC 65652-631AAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 death1 report
Recent MEDI-VAC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2021Break; Suction Failure; Break; Suction Failure
CUSTOMER REPORTED THE CANISTERS ARE BREAKING WITHIN 4 MONTHS THAT THEIR SHELF LIFE IS BECOMING SHORTER. CANISTER LOST SUCTION ON HIGH, LOW OR BOTH AND/OR CRACKED AT THE BASE AND SOMETIMES HAD DECREASED SUCTION DURING UNKNOWN PROCEDURE. CUSTOMER HAS STATED THEY USE (B)(6) WIPES TO CLEAN THEM DOWN AND LEAVE THE CANISTERS ON HIGH SUCTIONS 24/7 AND CLAMP OFF THE TUBING, THEREFORE THE CANISTERS ARE UNDER CONSTANT PRESSURE. THERE WAS NO REPORTED ADVERSE EVENT TO PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12872694 ↗MalfunctionNov 24, 2021Break; Crack; Suction Problem; Device Markings/Labelling Problem; Suction Failure; Break; Suction Failure
CUSTOMER REPORTED THE CANISTERS ARE BREAKING WITHIN 4 MONTHS OF USE AND THAT THEIR SHELF LIFE IS BECOMING SHORTER. CANISTER LOST SUCTION ON HIGH, LOW OR BOTH AND/OR CRACKED AT THE BASE AND SOMETIMES HAD DECREASED SUCTION DURING UNKNOWN PROCEDURE. CUSTOMER HAS STATED THEY USE CLINELL WIPES TO CLEAN THEM DOWN AND LEAVE THE CANISTERS ON HIGH SUCTIONS 24/7 AND CLAMP OFF THE TUBING. THERE WAS NO REPORTED ADVERSE EVENT TO PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY CUSTOMER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12872601 ↗InjuryMar 31, 2021Leak/Splash; Leak/Splash
DURING THE SUBSTITUTION OF THE DEVICE, IN PARTICULAR WHILE OPERATOR WAS DEACTIVATING THE VACUUM REMOVING THE RED TUBE, THE BIOLOGICAL LIQUID WHICH WAS COLLECTED IN THE DEVICE, CAME OUT FROM THE RED TUBE AND HIT THE HEALTH CARE PROFESSIONAL IN ONE EYE. THE HCP WAS THEN MONITORED TO IDENTIFY THE HEALTH STATUS AND TESTED FOR POSSIBLE INFECTIONS. ON TOP OF THAT, INAIL WAS INFORMED (SUBMITTER'S COMMENT: INAIL IS THE NATIONAL AUTHORITY WHICH MONITORS INJURY ON THE WORKING PLACE).
Patient problems: Exposure to Body Fluids
MAUDE report 11598926 ↗MalfunctionMar 18, 2021Suction Failure; Suction Failure
CUSTOMER REPORTED BROKEN CANISTER WITH A LOSS OF SUCTION BEFORE PLANNED C-SECTION SURGERY. ANOTHER DEVICE WAS OBTAINED TO FINISH THE PROCEDURE. THERE WAS A 5-MINUTE DELAY WITH NO INJURY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT DEMOGRAPHICS OR EVENT DATE WAS PROVIDED WHEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11517652 ↗MalfunctionMar 18, 2021Suction Failure; Suction Failure
CUSTOMER REPORTED BROKEN CANISTER WITH A LOSS OF SUCTION BEFORE PLANNED C-SECTION SURGERY. ANOTHER DEVICE WAS OBTAINED TO FINISH THE PROCEDURE. THERE WAS A 5-MINUTE DELAY WITH NO INJURY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11517625 ↗MalfunctionMar 18, 2021Suction Failure; Suction Failure
CLINICAL INFO CUSTOMER REPORTED BROKEN CANISTER WITH A LOSS OF SUCTION BEFORE EMERGENCY C-SECTION SURGERY. ANOTHER DEVICE WAS OBTAINED TO FINISH THE PROCEDURE. THERE WAS A 5-MINUTE DELAY WITH NO INJURY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11517604 ↗MalfunctionMar 18, 2021Suction Failure; Suction Failure
CUSTOMER REPORTED BROKEN CANISTER WITH A LOSS OF SUCTION BEFORE PLANNED C-SECTION SURGERY. ANOTHER DEVICE WAS OBTAINED TO FINISH THE PROCEDURE. THERE WAS A 5-MINUTE DELAY WITH NO INJURY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11517588 ↗MalfunctionMar 17, 2021Suction Failure; Suction Failure
CUSTOMER REPORTED BROKEN CANISTER WITH A LOSS OF SUCTION BEFORE EMERGENCY C-SECTION SURGERY. ANOTHER DEVICE WAS OBTAINED TO FINISH THE PROCEDURE. THERE WAS A 5-MINUTE DELAY WITH NO INJURY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11508020 ↗MalfunctionMar 17, 2021Suction Failure; Suction Failure
CUSTOMER REPORTED BROKEN CANISTER WITH A LOSS OF SUCTION DURING PLANNED C-SECTION SURGERY. ANOTHER DEVICE WAS OBTAINED TO FINISH THE PROCEDURE. THERE WAS A 5-MINUTE DELAY WITH NO INJURY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11507844 ↗MalfunctionDec 22, 2020Break
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER REPORTEDLY THE SUCTION CANNISTER WAS NOT WORKING EFFECTIVELY DESPITE BEING PLUGGED IN CORRECTLY. NOTED INNER CANNISTER WAS ALLEGEDLY CRUMPLING WITH SUCTION DESPITE MULTIPLE STAFF ENSURING IT WAS WORKING CORRECTLY. REPORTEDLY A NEW INNER CANNISTER PUT IN WITH SAME RESULTS. REPORTED A NEW OUTER CANNISTER WAS USED AND FOUND TO BE EFFECTIVE. IT WAS REPORTED WHEN SUCTION APPLIED ALONE WITHOUT BEING ATTACHED TO ANYTHING THAT INNER CANISTER WOULD REPORTEDLY CRUMPLE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11055195 ↗MalfunctionNov 17, 2020Crack; Decrease in Suction
CUSTOMER REPORTED THE CANISTER SUCTION 1500CC FLEX 65652-616 ARE CRACKING ALONG THE BOTTOM WHICH REDUCES THE SUCTION OF THE CONTAINER WHEN IN USE. CUSTOMER HAS USED DRESSING TAPE TO REPAIR. CUSTOMER CONFIRMS THEY KEEP THE SUCTION ON CONTINUOUSLY FOR CONSECUTIVE DAYS. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS (HEIGHT, WEIGHT, SEX, AGE) WERE PROVIDED AFTER NUMEROUS ATTEMPTS MADE TO OBTAIN. REPORT BEING FILED FOR MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10856206 ↗MalfunctionOct 19, 2020Crack; Decrease in Suction
BASED ON INFORMATION FROM THE CUSTOMER, ALLEGEDLY THE CANISTER IS NOT KEEPING SUCTION ON CONTINUOUSLY. THERE IS REPORTEDLY A CRACK IN THE BOTTOM OF CONTAINER. REPORTEDLY THE NURSES NOTICED THE CRACK IN THE BOTTOM OF THE CANISTER DURING THE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701694 ↗MalfunctionOct 19, 2020Crack; Suction Problem
BASED ON INFORMATION FROM THE CUSTOMER, ALLEGEDLY THE CANISTER IS NOT KEEPING SUCTION ON CONTINUOUSLY. THERE IS REPORTEDLY A CRACK IN THE BOTTOM OF CONTAINER. REPORTEDLY IT REDUCES THE SUCTION OF THE CANISTER WHEN IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701624 ↗MalfunctionOct 19, 2020Crack; Suction Failure
BASED ON INFORMATION FROM THE CUSTOMER, ALLEGEDLY THE CANISTER IS NOT KEEPING SUCTION ON CONTINUOUSLY. THERE IS REPORTEDLY A CRACK IN THE BOTTOM OF CONTAINER. REPORTEDLY IT REDUCES THE SUCTION OF THE CANISTER WHEN IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701554 ↗MalfunctionOct 19, 2020Suction Failure
BASED ON INFORMATION FROM THE CUSTOMER, ALLEGEDLY THE CANISTER IS NOT KEEPING SUCTION ON CONTINUOUSLY. THERE IS REPORTEDLY A CRACK IN THE BOTTOM OF CONTAINER. REPORTEDLY IT REDUCES THE SUCTION OF THE CANISTER WHEN IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701542 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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