Closed Wound Suction 0043650Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741049385), received between Apr 27, 2017 and Apr 15, 2026 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT CAME TO ACF SURGERY FOR DRAIN REMOVAL POST OP BREAST REDUCTION. CUSTOMER NOTICED WHEN DRAIN PULLED OUT WAS CUT NEAR DISTAL END OF DRAIN (STILL ATTACHED-BUT BARELY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888900 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S HEMOVAC DRAIN WAS FOUND LEAKING TWICE AND REPLACED 2/20. THE FIRST ONE WAS REPLACED BY THE UROLOGY TEAM ON MORNING ROUNDS, AND THE SECOND ONE WAS REPLACED BY NURSING AROUND 10:30. AS THE CNS, THEY WERE NOTIFIED ABOUT THIS ANOMALY AND HOW THE DRAINS WERE LEAKING AT THE SAME PLACE FOR EACH DEVICE. IT WAS LEAKING AT THE JUNCTURE OF THE TWO PRONGS. ORIGINAL PACKAGING FOR THE DEVICE IS UNAVAILABLE. THE FIRST ONE WAS PLACED IN OR AND THE SECOND WAS REPLACED ON 10. THE NURSE REPORTED TO THEM THAT ALL DRAINS WERE RECEIVED FROM THE OR AREA. PATIENT WAS FOUND WET FROM LEAKING DRAINS IN BOTH INSTANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644392 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER PLACING A EVACUATOR DRAIN TUBE IN THE OPERATING ROOM, BLOOD WAS FOUND TO BE LEAKING FROM THE BAG AFTER THE PATIENT WAS ADMITTED TO THE NEUROSURGERY WARD. IT WAS REPORTED THAT THERE WERE NO PROBLEMS IMMEDIATELY AFTER BEING ADMITTED TO THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768255 ↗
• MalfunctionDec 2, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT HOSPITAL WAS HAVING ISSUES WITH THE 400 CC THREE SPRING EVACUATOR. THEY WERE STILL HAVING COMPLAINTS FROM MD ABOUT THE NEW STYLE DAVOL DRAINS. A PHYSICIAN STATED THIS MORNING THAT WHEN OPENING A DRAIN THIS MORNING BLOOD PROJECTED OUT OF THE DRAIN ONTO THE PATIENT. HE STATED SOMETIMES IT TAKES TWO PEOPLE TO FULL CHARGE THE DRAIN FOR SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693145 ↗
• MalfunctionSep 5, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE NEW DRAIN WHEN YOU OPEN THEM, THEY HAVE SPRINGS INSIDE AND ARE THROWING BLOOD OUT OF THE DRAIN. THIS IS A SAFETY ISSUE, AS HAD SEVERAL NURSE VOICE CONCERNS. DOCTOR ALSO STATED THEY HAD THIS SAME TYPE OF DRAINS MANY YEARS AGO AND HAD MANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977863 ↗
• MalfunctionAug 28, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE NEW DRAIN WHEN YOU OPEN THEM THEY HAVE SPRINGS INSIDE AND ARE THROWING BLOOD OUT OF THE DRAIN. THIS IS A SAFETY ISSUE, AS HAD SEVERAL NURSE VOICE CONCERNS. DOCTOR ALSO STATED THEY HAD THIS SAME TYPE OF DRAINS MANY YEARS AGO AND HAD MANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915326 ↗
• MalfunctionJul 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE USING THE EVACUATOR, THE Y CONNECTOR WAS TORN, AND WASTE LIQUID WAS LEAKING OUT. A NEW PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588778 ↗
• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DRAIN OF THE SPRING EVACUATOR WAS LEAKING. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL 06MAY2025, STATED THAT THE NO REPORT OF IMPACT ON PATIENT. NO INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009541 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THE FOLLOWING TWO PROBLEMS HAD OCCURRED IN THE SPRING EVACUATOR. SPRING EVACUATOR EXPANDS EVEN THOUGH IT WAS CLAMPED. LEAKS WERE OCCURRING FROM THE CRIMPED PART AT THE END. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 02APR2025, CUSTOMER CONFIRMED THAT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882322 ↗
• MalfunctionApr 17, 2025Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE FOLLOWING TWO PROBLEMS HAD OCCURRED IN THE SPRING EVACUATOR. SPRING EVACUATOR EXPANDS EVEN THOUGH IT WAS CLAMPED. LEAKS WERE OCCURRING FROM THE CRIMPED PART AT THE END. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 02APR2025, CUSTOMER CONFIRMED THAT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855771 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PATIENT CAME TO ALF SURGERY FOR DRAIN REMOVAL POST OP BREAST REDUCTION. WRITER NOTICED WHEN DRAIN PULLED OUT IT WAS CUT NEAR DISTAL END OF DRAIN (STILL ATTACHED - BUT BARELY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697044 ↗
• MalfunctionDec 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER ABOUT THREE DAYS OF USE, THE SPRING EVACUATOR TUBE WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831384 ↗
• MalfunctionJul 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT WOUND DRAIN CONNECTION OF Y-SHAPED TUBE CRACKED AFTER A SHORT PERIOD OF USE (USED ON (B)(6) 2024) AND WASTE FLUID WAS LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791947 ↗
• MalfunctionJul 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE Y CONNECTOR OF THE CLOSED WOUND SUCTION KIT BROKE ON THE DAY OF USE, SO IT WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689741 ↗
• MalfunctionJul 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DAY IT WAS USED, THE Y-CONNECTOR OF THE CLOSED WOUND SUCTION KIT RIPPED, SO THE USE OF THE Y-CONNECTOR WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666401 ↗
• MalfunctionJul 3, 2024Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE Y CONNECTOR OF THE WOUND SUCTION BROKE ON THE DAY OF USE, SO IT HAS BEEN DISCONTINUED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665796 ↗
• MalfunctionJul 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE Y CONNECTOR OF THE WOUND SUCTION BROKE ON THE DAY OF USE, SO IT HAS BEEN DISCONTINUED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665285 ↗
• MalfunctionJun 19, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT WHEN THEY TRIED TO USE SPRING EVACUATOR, THERE WAS NO PRESSURE AND THEY COULD NOT SUCK IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566933 ↗
• MalfunctionMay 22, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC WOUND DRAIN CAME APART FREQUENTLY. THEY WERE TAPING PRODUCT TOGETHER, SO IT DID NOT COME APART. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 09MAY2024, CUSTOMER HAD AN INCREASE PROBLEM WITH THE DRAINS PULLED APART. NO ADDITIONAL PATIENT IMPACT FROM THIS EVENT JUST THAT THE DRAINAGE WAS NOT SUCTIONED OR DRAINED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369991 ↗
• MalfunctionMay 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DRAIN TUBING WOULD NOT COME OUT OF BACK. ONE OF THE TWO DRAINAGE TUBES WAS REMOVED EASILY, OTHER ONE MET SIGNIFICANT RESISTANCE. CLINICIAN CAME OVER TO REMOVE DRAIN. WHILE PULLING ON DRAIN TUBING A PORTION OF TUBING SNAPPED OFF INSIDE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277269 ↗
• MalfunctionNov 20, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE DRAIN BAG AND THE TUBE WAS LOOSE AND COULD NOT BE CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169126 ↗
• MalfunctionJul 20, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT SOON AFTER PLACEMENT, THE DEVICE WAS UNABLE TO SUCTION. ASPIRATION COULD NOT BE PERFORMED IMMEDIATELY AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360494 ↗
• MalfunctionApr 20, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE NURSE HAD A MEDICAL PROCEDURE AND HAD THE BD WOUND DRAINS, ACCESSORIES, EVACUATOR, THREE-SPRING, Y-CONNECTOR SKU 0043650 AND IT WAS CLOGGING. THEY HAD TO REMOVE THE CLOG EVERY TWO HOURS USING TOOTHPICK AND THERE WAS A LOT OF FLUID BACKING UP AND IT DID NOT MOVE THROUGH THE EVACUATOR. NURSE STATED THAT THEY WILL TAKE A PICTURE TO SHOW THE PROBLEM AND REQUESTED FOR THE REPLACEMENT AS SOON AS POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778544 ↗
• MalfunctionMar 1, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN OPENING THE STERILE PACKAGE THEY FOUND A HAIR ON THE INSIDE OF THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459711 ↗
• MalfunctionJan 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF SUCTION EVACUATOR FROM THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183365 ↗