MEDI-VAC 65652-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10630140153860), received between Apr 14, 2017 and Mar 18, 2021 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701493 ↗
• MalfunctionOct 19, 2020Crack; Decrease in Suction; Leak/Splash

  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. NURSES HAD ATTEMPTED TO TAPE THE CRACK ON THE BOTTOM OF THE CANISTER, IT REPORTEDLY CONTINUED TO LEAK SO WAS REPLACED WITH A NEW CANISTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701439 ↗
• MalfunctionOct 19, 2020Crack; Leak/Splash

  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. NURSES HAD ATTEMPTED TO TAPE THE CRACK ON THE BOTTOM OF THE CANISTER, IT REPORTEDLY CONTINUED TO LEAK SO WAS REPLACED WITH A NEW CANISTER.

  Patient problems: Insufficient Information

  MAUDE report 10701377 ↗
• MalfunctionApr 14, 2017Break; Detachment Of Device Component; Kinked

  OVER THE LAST 4 - 5 WEEKS THE BOTTOM OF SIX OF THE FLEXI WALL MOUNTED CANISTERS HAS BROKEN OFF IN THE ICU AREA. WHEN A PATIENT IS IN THE BED IN ICU THE SUCTION CANISTERS ARE LEFT ON CONSTANTLY AND THE TUBING GOING TO THE PATIENT IS KINKED AND TUCKED NEAR THE PATIENTS HEAD. THE LATEST EVENT OCCURRED WHILE PERFORMING LIFE SAVING SUCTIONING. IT HAS HAPPENED WITH BOTH OLD AND NEW CANISTERS. NO INFORMATION IS AVAILABLE FOR THE PREVIOUS INCIDENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6493937 ↗