CRD 65651-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50630140152656), received between Aug 21, 2020 and Mar 10, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2022Suction Failure; Suction Failure

  CUSTOMER REPORTED THAT WHEN THE SUCTION CANISTER WAS REPLACED DURING AN EMERGENCY C-SECTION, IT HAD NO SUCTION AND THE LINER WAS BEING CRUSHED WITHIN THE HARD SHELL AS IF THE VACUUM PRESSURE WAS SUCTIONING AROUND THE LINER INSTEAD OF WITHIN THE LINER. THERE WAS A 5-7 MINUTE DELAY TO CHANGE OUT TO A NEW CANISTER WITH NO ADVERSE EVENT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726469 ↗
• MalfunctionAug 21, 2020Suction Failure

  BASED ON THE REPORT FROM THE CUSTOMER REPORTEDLY THE PPV FILTER IS PREVENTING SUCTION FROM PERFORMING PROPERLY. WHEN THE PPV FILTER WAS REMOVED FROM THE CANISTER LID, THERE WERE NO ISSUES WITH SUCTION. THERE WAS NO LIQUID IN THE CANISTER AT THE TIME OF SUCTION ISSUE, SO IT WAS NOT A CASE WHERE LIQUID TOUCHED THE FILTER ENGAGING THE SUCTION TO CEASE. REPORTEDLY THE PATIENT HAD AN EXTERNAL FEMALE CATHETER IN PLACE, AND THE PATIENT HAD BEEN FOUND SOAKED IN URINE, AND THE SUCTION CANISTER WAS EMPTY. THERE WERE NO INJURIES NOTED AND NO ADDITIONAL MEDICAL TREATMENT PROVIDED SINCE THE PATIENT ONLY NEEDS TO BE CLEANED UP.

  Patient problems: No Code Available

  MAUDE report 10438685 ↗
• MalfunctionAug 21, 2020Suction Failure

  BASED ON THE REPORT FROM THE CUSTOMER REPORTEDLY THE PPV FILTER IS PREVENTING SUCTION FROM PERFORMING PROPERLY. WHEN THE PPV FILTER WAS REMOVED FROM THE CANISTER LID, THERE WERE NO ISSUES WITH SUCTION. THERE WAS NO LIQUID IN THE CANISTER AT THE TIME OF SUCTION ISSUE, SO IT WAS NOT A CASE WHERE LIQUID TOUCHED THE FILTER ENGAGING THE SUCTION TO CEASE. REPORTEDLY THE PATIENT HAD AN EXTERNAL FEMALE CATHETER IN PLACE, AND THE PATIENT HAD BEEN FOUND SOAKED IN URINE, AND THE SUCTION CANISTER WAS EMPTY. THERE WERE NO INJURIES NOTED AND NO ADDITIONAL MEDICAL TREATMENT PROVIDED SINCE THE PATIENT ONLY NEEDS TO BE CLEANED UP.

  Patient problems: No Code Available

  MAUDE report 10438482 ↗
• MalfunctionAug 21, 2020Therapeutic or Diagnostic Output Failure

  BASED ON THE REPORT FROM THE CUSTOMER REPORTEDLY THE PPV FILTER IS PREVENTING SUCTION FROM PERFORMING PROPERLY. WHEN THE PPV FILTER WAS REMOVED FROM THE CANISTER LID, THERE WERE NO ISSUES WITH SUCTION. THERE WAS NO LIQUID IN THE CANISTER AT THE TIME OF SUCTION ISSUE, SO IT WAS NOT A CASE WHERE LIQUID TOUCHED THE FILTER ENGAGING THE SUCTION TO CEASE. THE ISSUE WAS DISCOVERED WHEN PATIENT WAS FOUND REPORTEDLY COVERED IN GASTRIC CONTENTS, AND SUCTION CANISTER WAS EMPTY. PER THE CUSTOMER, THERE WAS NO INJURY, THE PATIENT IS STABLE, THEY DID NOT NEED ANY MEDICAL INTERVENTIONS, JUST TO BE CLEANED UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10438374 ↗