Closed Wound Suction 0034610Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00801741049125), received between Apr 13, 2017 and Apr 21, 2021 — classified as 5 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (20 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2021Disconnection; Difficult to Remove; Disconnection; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS AN UNSUCCESSFUL DRAIN REMOVAL FROM KNEE. THE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM FOR REMOVAL OF THE DRAIN TIP. IT WAS NOTED THAT THE DRAIN'S PLUG WAS INTACT AFTER REMOVAL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702525 ↗
• MalfunctionApr 20, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE BALLOON OF THE WOUND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694535 ↗
• MalfunctionJan 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL LIKE BLACK STAINS WERE FOUND ON THE INSIDE OF THE EVACUATOR WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11118609 ↗
• MalfunctionDec 6, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE EVACUATOR WAS DIFFICULT TO ASPIRATE ON THE DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10955795 ↗
• MalfunctionNov 2, 2020Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE EVACUATOR WAS UNABLE TO SUCTION COMPLETELY DUE TO THE BALLOON DEFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10770321 ↗
• MalfunctionJul 30, 2020Difficult to Insert; Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE TROCAR ANGLE CHANGED WHEN DRAINING SPINE, WHICH MADE THE TROCAR DIFFICULT TO INSERT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10346094 ↗
• MalfunctionJul 30, 2020Difficult to Insert; Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE TROCAR ANGLE CHANGED WHEN DRAINING SPINE, WHICH MADE THE TROCAR DIFFICULT TO INSERT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10346037 ↗
• MalfunctionMay 21, 2020Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE SUCTION EVACUATOR ON THE 3RD DAY OF USE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10080759 ↗
• MalfunctionApr 28, 2020Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE SUCTION EVACUATOR.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10006416 ↗
• MalfunctionApr 2, 2020Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FIRST HEALTH OF THE CAROLINAS RECEIVED DRAIN BAGS THAT HAD A FLUID INSIDE. THE AMOUNT OF FLUID WAS LESS THAN HALF A CC (A FEW DROPS). THE FACILITY HAS USED THE DRAIN BAGS ON PATIENTS. NO MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9915404 ↗
• MalfunctionMar 21, 2020Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE AT THE TIME OF SUCTION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9863584 ↗
• MalfunctionMar 11, 2020Inflation Problem; Pressure Problem; Appropriate Device Problem Term/Code Not Available; Inflation Problem

  IT WAS REPORTED THAT THE RELIAVAC 400 WOULD NOT HOLD PRESSURE. ONCE THE INLET TUBE WAS REPLACED THE DEVICE WORKED AS DESIGNED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9819113 ↗
• MalfunctionFeb 19, 2020Difficult to Remove; Pressure Problem; Difficult to Remove

  IT WAS REPORTED THAT IT WAS UNABLE TO ASPIRATE, AS NEGATIVE PRESSURE WAS NOT APPLIED EFFECTIVELY ALTHOUGH THE BALLOON WAS INFLATED DURING A PRETEST.

  Patient problems: No Patient Involvement

  MAUDE report 9727615 ↗
• MalfunctionFeb 7, 2020Inflation Problem

  IT WAS REPORTED THAT THE RELIAVAC BALLOON EVACUATOR WAS DIFFICULT TO INFLATE THE INTERNAL BALLOON, AND WOULD NOT HOLD VACUUM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9683019 ↗
• MalfunctionJan 6, 2020Break; Crack; Fluid/Blood Leak; Break

  IT WAS REPORTED THAT A CRACK IN THE Y CONNECTOR ON THE EVACUATOR WAS FOUND DUE TO A LEAK OF FLUID.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9554748 ↗
• MalfunctionDec 26, 2019Inflation Problem

  IT WAS REPORTED THAT THE RELIAVAC WAS DIFFICULT TO INFLATE THE BALLOON ON THE DAY OF USE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9520836 ↗
• MalfunctionDec 19, 2019Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE SUCTION DEVICE DURING USE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9497958 ↗
• MalfunctionNov 19, 2019Break

  IT WAS REPORTED THAT THE DRAIN TUBE ON THE RELIAVAC EVACUATOR BROKE WHEN THE USER PULLED IT WITH MOSQUITO FORCEPS WHILE REMOVING THE DEVICE FROM THE PATIENT. THIS OCCURRED ON THE 2ND DAY OF USE. IT WAS LATER REPORTED FROM THE INTERNATIONAL BUSINESS CENTER (IBC) VIA EMAIL (B)(6) 2019 THAT THE BREAK IN THE TUBE OCCURRED NEAR THE DRAIN HOLES ON THE END OF THE TUBE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9342288 ↗
• MalfunctionNov 19, 2019Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE RELIAVAC COULD NOT BE INFLATED ON THE DAY OF USE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9341026 ↗
• MalfunctionNov 5, 2019Inflation Problem; Suction Problem

  IT WAS REPORTED THAT THE RELIAVAC WAS UNABLE TO ASPIRATE DURING PRETEST. ANOTHER DEVICE WAS USED. IT WAS LATER REPORTED FROM THE INTERNATIONAL BUSINESS CENTER (IBC) VIA EMAIL 24OCT2019 THAT THE USER ALLEGED THE BALLOON INSIDE DID NOT EXPAND.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9279709 ↗
• MalfunctionOct 25, 2019Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE BALLOON AFTER PLACEMENT, ON THE DAY OF USE. THE USER DISCONTINUED TO USE THE SUCTION EVACUATOR DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9238931 ↗
• MalfunctionSep 16, 2019Inflation Problem

  IT WAS REPORTED THAT THE EVACUATOR BALLOON WAS DIFFICULT TO INFLATE PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9072530 ↗
• MalfunctionJul 23, 2019Suction Problem; Suction Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT IT WAS DIFFICULT TO ASPIRATE THE EVACUATOR AS NEGATIVE PRESSURE WAS APPLIED DURING USAGE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8817717 ↗
• MalfunctionApr 9, 2019Disconnection

  IT WAS REPORTED THAT THE Y CONNECTOR DISCONNECTED FROM THE DRAINAGE TUBE ON THE EVACUATOR BULB.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8497381 ↗
• MalfunctionMar 28, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON RUPTURED A DAY AFTER USE. IT WAS LATER REPORTED VIA EMAIL ON 18 MARCH 2019 FROM THE INTERNATIONAL BUSINESS CENTER (IBC) REPRESENTATIVE, IT IS UNKNOWN IF THERE WERE MISSING PIECES FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8458968 ↗