Closed Wound Suction 0043630Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741049378), received between Aug 21, 2020 and Jun 17, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE Y-TUBE PORTION OF WOUND DRAINAGE AFTER ABOUT ONE DAY OF INDWELLING, AND SUCTION BECAME IMPOSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235231 ↗
• MalfunctionJan 8, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE HEMOVACS BECOMING DISCONNECTED FROM THE WOUND DRAINAGE KIT TUBING ON ORTHO AND NEUROSURGERY PATIENTS. THE REPRESENTATIVE HAD WORKED ON THIS IN THE PAST AND THOUGHT IT HAD IMPROVED. THE CUSTOMER WONDERING IF THERE HAVE BEEN ANY CHANGES TO THE HEMOVACS OR IF THERE WAS SOMETHING MORE, THEY SHOULD BE DOING BESIDES TAPING IT TO THE PATIENTS. THE CUSTOMER REPORTED ISSUES WITH PCN# 0043630, PCN# 0073610. PER FOLLOW UP VIA PHONE ON 27DEC2024. THIS IS BEING REPORTED BY OUR SHORT STAY UNIT, SO THIS WAS POST-SURGERY. IT HAPPENED OCCASIONALLY, AND FROM WHAT THEY UNDERSTAND WAS NOT A NEW PROBLEM. THE RNS REPORTED TAPING THE TUBING BEFORE SENDING PATIENTS HOME SO THAT IT DID NOT COME DISCONNECTED. THEY ARE NOT SURE WHICH DRAIN IT WAS HAPPENING WITH, AND WOULD GUESS BOTH, ALSO HAVE HAD REPORTED OF IT HAPPENING ON KNEE SURGERIES AND SPINE SURGERIES. IN THE PAST, THE SOLUTION WAS TO TAP THE CONNECTION, BUT CUSTOMER WAS HOPING THERE WOULD BE A WAY TO ENSURE THAT THE CONNECTION WAS MORE SECURE. LOOKING IN THE CHART OF ONE OF THE LAST ONES THEY HAD AND SEEING A 10F 400CC RESERVOIR DRAIN. PER SURGEON NOTED A MEDIUM HEMOVAC ALSO NOT SURE HOW TO FIGURE OUT THE EXACT ONE THAT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103379 ↗
• InjuryFeb 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT SURGERY WAS DONE ON (B)(6) 2023 AND ON POST OPERATIVE DA 4, WHEN THE HEMOVAC DRAIN WAS BEING REMOVED THERE WAS NOTED TO BE A BREAK IN THE TUBING. COMPUTED TOMOGRAPHY (CT) SCAN DID NOT SHOW RESIDUAL DRAIN TO BE SUPERFICIAL ENOUGH TO REMOVE IT AT BEDSIDE. PATIENT RETURNED TO THE OPERATING ROOM (OR) ON (B)(6) 2023 AND THE PORTION OF THE DRAIN THAT WAS RETAINED WAS REMOVED IN ITS ENTIRETY. REMOVAL OF THE DRAIN SURGERY WAS DONE ON THE SAME ADMISSION AS THE ORIGINAL SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16452426 ↗
• MalfunctionOct 25, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT Y CONNECTOR WAS DISCONNECTED AND THE WOUND DRAIN DEVICE COULD NOT BE USED. IT WAS MENTIONED THAT HEALTH DAMAGE TO THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666944 ↗
• MalfunctionJul 13, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CONNECTOR OF THE EVACUATOR WAS LOOSE AND IT WAS UNABLE TO CONNECT ON THE DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002792 ↗
• MalfunctionJun 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WASTE FLUID LEAKED FROM THE CONNECTION BETWEEN THE BAG AND THE TUBE ON THE NEXT DAY OF THE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054547 ↗
• MalfunctionJun 10, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLOSED WOUND SUCTION KIT WAS FALLING APART AT THE POINT WHERE STICK THE TUBING INTO THE ACCORDION DRAIN. THE DRAINS WERE PUT TOGETHER IN THE OPERATING ROOM AND FOUND THAT THE DRAINS WERE EASY TO DISCONNECT WHEN THE TUBING WAS NOT INSERTED FULLY. PER FOLLOW UP ON 16JUN2021 THE CUSTOMER STATED IT WAS UNKNOWN WHETHER THE USER WAS INSERTING THE TROCAR TOO FAR INTO THE TUBING RESULTING IN DIFFICULTY IN REMOVAL OR SEPARATION. THE ISSUE OCCURRED WHEN THE NURSING STAFF CAME TO FIND THE TUBING DETACHED FROM THE DRAIN ON A POST OPERATIVE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977270 ↗
• MalfunctionMay 12, 2021Material Split, Cut or Torn; Suction Failure; Material Split, Cut or Torn; Suction Failure

  IT WAS REPORTED THAT A HOLE WAS FOUND ON THE WOUND DRAIN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812302 ↗
• MalfunctionFeb 18, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE HEMOVAC DID NOT HOLD SUCTION AFTER BEING EMPTIED. THE DEVICE WAS LATER REPLACED HOWEVER, THE REPLACEMENT DID NOT MAINTAIN SUCTION.

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

  MAUDE report 11344983 ↗
• MalfunctionFeb 17, 2021Fluid/Blood Leak; Suction Failure

  IT WAS REPORTED THAT THE HEMOVAC DID NOT HOLD SUCTION AFTER BEING EMPTIED AND LATER THE HEMOVAC WAS REPLACED, HOWEVER THE REPLACED HEMOVAC ALSO DID NOT MAINTAIN SUCTION. PER FOLLOW UP VIA EMAIL ON 19FEB2021, THE DEVICE WAS IN USE FOR 12 HOURS.

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

  MAUDE report 11338429 ↗
• MalfunctionDec 21, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE PLASTIC PART OF THE BOTTOM WAS FOLDED AND STUCK TOGETHER, WHEN THE POSITIVE PRESSURE WAS ACT ON THE WOUND SUCTION. PER FOLLOW UP VIA IBC ON 17DEC2020, IT WAS CLARIFIED BY IBC THAT THE BOTTOM OF THE DEVICE WAS FOLDED AND STUCK TOGETHER BECAUSE POSITIVE PRESSURE WAS ACTED.

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

  MAUDE report 11044499 ↗
• MalfunctionNov 24, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBE CAME APART AT 2 DIFFERENT SITES. PER FOLLOW UP INFORMATION RECEIVED ON 03NOV2020, IT WAS INDICATED THAT THE PRODUCT WAS INSERTED IN THE OR WHERE THE PATIENT CAME UP TO THE NURSING UNIT WITH THE HEMOVAC IN PLACE. THE PATIENT WAS NOT ABLE TO COLLECT CONTAMINATED DRAINS AND IMPACT TO THE PATIENTS DUE TO THE REPORTED EVENTS WAS NOT DETERMINED AS WELL. THIS WAS RECOMMENDED TO BE CROSS REFERENCED WITH THE FIELD REPORTS FOR PO INFECTIONS DUE TO BREAK IN PORTAL. ALSO INDICATED FOR AN EVENT REGARDING RN, SPLASHING OF BLOOD PRODUCT. RN ADDED TAPE TO THE SITE WHERE THE TUBING WAS CONNECTED TO IMPROVE EFFICIENCY.

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

  MAUDE report 10896600 ↗
• MalfunctionSep 24, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND IN THE STERILE PACKAGE, NOTICED WHILE OPENING THE KIT DURING A SURGICAL CASE. THE PRODUCT WAS REMOVED FROM THE OPERATING ROOM SAFELY.

  Patient problems: Insufficient Information; No Patient Involvement

  MAUDE report 10580418 ↗
• InjuryAug 21, 2020Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE WOUND DRAIN WAS DISCONNECTED FROM THE PATIENT. THE WOUND DRAIN WAS NOW CONTAMINATED AND HAD TO BE DISCONTINUED FROM PATIENT'S RIGHT KNEE. UPON INITIAL ATTEMPT TO PULL DRAIN, RESISTANCE WAS MET. MULTIPLE ATTEMPTS WERE MADE TO BEND AND STRAIGHTEN THE KNEE AS THE DRAIN POTENTIALLY GOT CAUGHT ON THE KNEE IMPLANT. MULTIPLE ANGLES ALSO ATTEMPTED TO DISCONTINUE THE DRAIN WITHOUT INCIDENT. CALLED REGISTERED NURSE FOR ADDITIONAL ASSISTANCE WITH MANIPULATING THE LEG TO DISCONTINUE THE DRAIN. WHEN DRAIN WAS DISCONTINUED, THERE WAS A POP-LIKE MOTION. A JAGGED TIP WAS SEEN AND 6 EYELETS WERE VISUALIZED. MEDICAL DOCTOR WAS NOTIFIED FOR X-RAY ORDER, X-RAY SHOWED THE FRAGMENT IN THE KNEE AND THE PATIENT WAS TAKEN BACK TO SURGERY FOR REMOVAL OF THE DRAIN TIP. THE DRAIN WAS INSERTED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020. PER ADDITIONAL INFORMATION RECEIVED ON 19AUG2020 FROM THE COMPLAINANT, THE RETAINED PORTION WAS SUCCESSFULLY REMOVED AND THE PATIENT INCURRED NO ADVERSE OUTCOMES AFTER REMOVAL.

  Patient problems: Foreign Body In Patient; No Code Available; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 10440052 ↗
• MalfunctionAug 21, 2020Break; Disconnection; Difficult to Remove; Contamination /Decontamination Problem; Disconnection

  IT WAS REPORTED THAT THE WOUND DRAIN WAS DISCONNECTED FROM THE PATIENT. THE WOUND DRAIN WAS NOW CONTAMINATED AND HAD TO BE DISCONTINUED FROM PATIENT'S RIGHT KNEE. UPON INITIAL ATTEMPT TO PULL THE DRAIN, RESISTANCE WAS MET. MULTIPLE ATTEMPTS WERE MADE TO BEND AND STRAIGHTEN THE KNEE AS THE DRAIN POTENTIALLY GOT CAUGHT ON THE KNEE IMPLANT. MULTIPLE ANGLES ALSO ATTEMPTED TO DISCONTINUE THE DRAIN WITHOUT INCIDENT. CALLED REGISTERED NURSE FOR ADDITIONAL ASSISTANCE WITH MANIPULATING THE LEG TO DISCONTINUE THE DRAIN. WHEN DRAIN WAS DISCONTINUED, THERE WAS A POP-LIKE MOTION. A JAGGED TIP WAS SEEN AND 6 EYELETS WERE VISUALIZED. MEDICAL DOCTOR WAS NOTIFIED FOR X-RAY ORDER, X-RAY SHOWED THE FRAGMENT IN THE KNEE AND THE PATIENT WAS TAKEN BACK TO SURGERY FOR REMOVAL OF THE DRAIN TIP. THE DRAIN WAS INSERTED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020.

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

  MAUDE report 10439949 ↗