Closed Wound Suction 0043600Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741049347), received between Apr 13, 2017 and Jul 16, 2026 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Disconnection” (15 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Incorrect Measurement

  THE CUSTOMER REPORTED A BD HEMOVAC DRAINS POSSIBLE DESIGN OR MANUFACTURING CHANGE. THEY STATED THAT, IN THE PAST, THE DRAIN PERFORATIONS EXTENDED TO THE END OF THE TUBING; HOWEVER, RECENTLY RECEIVED PRODUCTS HAD PERFORATIONS LOCATED IN THE MIDDLE SECTION OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849848 ↗
• MalfunctionOct 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN WOUND EVACUATOR WAS USED, A LEAK WAS CONFIRMED. THE LOCATION OF THE LEAK WAS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23191104 ↗
• MalfunctionJul 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT HAD HEMOVAC DRAIN CLOSED WOUND SUCTION EVACUATION DEVICE TO THE BACK INCISION NEAR THE SPINE. HEMOVAC DRAIN WAS TAPED AND PREVIOUSLY WORKING. WITH REPOSITIONING DEVICE HAD DISCONNECTED AT THE TUBING AND IMMEDIATELY ADDRESSED. DEVICE WAS REMOVED FROM PATIENT AS PER ORDER PROMPTLY. PATIENT HAD SURGERY LIKE T10 - S1 INSTRUMENTATION AND FUSION OF SPINAL COLUMNS. DRAIN WAS USED TO REMOVE EXCESS DRAINAGE FROM SURGERY SITE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 09JUL2025, IT WAS REPORTED THAT NURSING STAFF HAVE TRIED TO PREVENT THIS BY TAPING THE TUBING BUT WAS CLEARLY INEFFECTIVE REGARDLESS. THE SITE CLOSEST TO PATIENT WAS CLEANSED WITH CHOLORHEXADINE. DEVICE WAS REMOVED FROM PATIENT AS PER ORDER PROMPTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395499 ↗
• MalfunctionJul 1, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC DRAIN DISCONNECTED FROM THE Y SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372723 ↗
• MalfunctionJul 1, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT PATIENT'S HEMOVAC HAD COME APART AFTER THEY ROLLED ONTO THEIR SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372714 ↗
• MalfunctionJun 16, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC DAVOL CLOSED WOUND SUCTION EVACUATOR TUBING CAME OUT AT THE DEVICE SITE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 11JUN2025, STATED THAT THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211141 ↗
• MalfunctionJun 16, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT HEMOVAC WOUND DRAIN DISCONNECTED FROM THE TUBE EVEN WITH TAPE ON IT. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 11JUN2025, STATED THAT THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211129 ↗
• MalfunctionJun 12, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE HEMOVAC DRAIN DISCONNECTED FROM THE Y SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192417 ↗
• MalfunctionJun 11, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC WOUND DRAIN WAS DISCONNECTED FROM THE Y SITE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 11JUN2025, STATED THAT THERE WAS NO PATIENT HARM REPORTED, AND THE TROUBLESHOOTING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183893 ↗
• MalfunctionMay 2, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE HEMOVAC DISCONNECTED FROM THE RESERVOIR. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 30APR2025, CUSTOMER STATED THAT ADDED CARE TIME TO PATIENT AND EXPOSED TO OPEN SYSTEM, POTENTIAL FOR PATIENT HARM. CURRENTLY STAFF WERE TAPING THE DRAINS AS A PRECAUTION WHEN THEY WERE OUT OF THE OPERATING ROOM OR AFTER THEY HAD FALLEN APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951230 ↗
• MalfunctionApr 23, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT SILICONE EVACUATOR HEMOVAC DISCONNECTED FROM THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892860 ↗
• MalfunctionApr 22, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WOUND DRAINAGE HEMOVAC GOT DISCONNECTED FROM THE RESERVOIR AS PATIENT WAS TRYING TO MOBILIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882368 ↗
• MalfunctionApr 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC DISCONNECTED FROM PATIENT. THERE WAS NO SERIOUS HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873059 ↗
• MalfunctionApr 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC DISCONNECTED FROM THE PATIENT. THERE WAS NO SERIOUS HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872660 ↗
• MalfunctionApr 7, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE HEMOVAC CONTAINER OF THE WOUND DRAIN WAS DISCONNECTED FROM PATIENT AT THE Y-SITE, EVEN THOUGH CONNECTION POINT WAS TAPED. DISCONNECTED FROM PATIENT FROM UNKNOWN AMOUNT OF TIME. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 02APR2025, THE DEVICE HAS BEEN RETAINED AND COULD BE SENT BACK TO BD. IT WAS CONTAMINATED WITH FLUID FROM THE PATIENT IT WAS ATTACHED TO. AS PER THE SHIPPING LABEL EMAIL THEY WOULD NEED A CANISTER TO RETURN IT TO THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21784537 ↗
• MalfunctionMar 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HEMOVAC LEAKED YESTERDAY. WHEN THE STAFF WENT TO REPLACE IT, THEY DISCOVERED IT WAS CRACKED. THE PHYSICIAN ASSISTANT SWITCHED IT OUT AND THEY SAID THEY DO TRIM THE TUBING, WHICH THEY DID IN THIS CASE BECAUSE IT WAS TOO LONG AND CUT IT AT AN ANGLE BEFORE CONNECTING IT TO Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653520 ↗
• MalfunctionMar 20, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE HEMOVAC LEAKED YESTERDAY. WHEN THE STAFF WENT TO REPLACE IT, THEY DISCOVERED IT WAS CRACKED. THE PHYSICIAN ASSISTANT SWITCHED IT OUT AND THEY SAID THEY DO TRIM THE TUBING, WHICH THEY DID IN THIS CASE BECAUSE IT WAS TOO LONG AND CUT IT AT AN ANGLE BEFORE CONNECTING IT TO Y.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652697 ↗
• MalfunctionJan 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A CONNECTOR ON THE HEMOVAC CRACKED AND WAS LEAKING DURING THE HEMOVAC DRAIN INSERTION PROCEDURE. THE PATIENT FELT INCONVENIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 21180369 ↗
• MalfunctionJan 16, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT CUSTOMER HAD ISSUES WITH THE DULLNESS OF THE TROCAR. THE TROCAR WAS LACKING IN SHARPNESS, AND THE CUSTOMER WAS CONSIDERING SWITCHING TO COMPETITOR. CUSTOMER HAD DIFFICULTIES PASSING THE DRAIN BECAUSE OF THE TROCAR DULL. THEY PREFERRED TO USE THE MEDLINE DRAINS THAT THEY USED AT A DIFFERENT FACILITY. PER ADDITIONAL INFORMATION RECEIVED ON 27DEC2024, IT WAS REPORTED THAT THE ITEMS WERE #0043600 AND #0043610. THERE WAS NO IMPACT TO THE PATIENT AND NO MEDICAL INTERVENTION. THEY HAD BEEN HAVING PROBLEMS PASSING THE TROCAR THROUGH THE SKIN BECAUSE OF THE DULLNESS OF IT, IT HAD BEEN VERY HARD TO PASS IT ALL THE WAY WITHOUT ALMOST GETTING POKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169561 ↗
• MalfunctionDec 26, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THEY WERE CONTINUING TO HAVE ISSUES WITH THEIR HEMOVAC. THERE HAS NOT BEEN A FOLLOW-UP SINCE THE INCONCLUSIVE REPORT. IT HAPPENED AT THE "Y" CONNECTION OF THE PORT, IN RECOVERY WHEN THE PATIENT WAS GETTING DRESSED OR WORKING WITH PHYSICAL THERAPY, IT WOULD DISCONNECT CAUSING BLOOD TO COME FROM THE DRAIN AND THEY WOULD HAVE TO RECONNECTED ALSO TRIED TO REINFORCE THE DRAIN PORT WITH TAPE BUT OFTEN STILL HAD PROBLEMS. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 06DEC2024, IT WAS REPORTED THAT THE NURSES WERE TAPING IT DOWN BEFORE THE PATIENT LEAVES BUT WHEN THEY WERE DOING POST OP CALLS, PATIENTS WERE COMPLAINING ABOUT IT COMING APART. THE NURSES HAD ALSO SAID WHEN THEY WERE GETTING PATIENTS DRESSED, THEY HAD COME APART AND OF COURSE CAUSED BLEEDING ALL OVER THE PATIENT. THE NURSES STATED THAT THE TUBING THAT LOOKS LIKE A Y SECTION THAT CONNECTS WITH THE VAC ITSELF IS WHERE IT WAS COMING APART (LOT#: NGHT2525, LOT#: UNK, LOT#: NGEQ3519).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21018787 ↗
• InjurySep 20, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC WOUND DRAIN WILL COME APART WHEN PATIENT WAS MOVING FOR OVERNIGHT. THE BLOOD SHOT INTO PHYSICAL THERAPIST'S EYE BECAUSE IT CAME LOOSE AND DID NOT HAVE A LOCK LIKE A JP DRAIN.

  Patient problems: Exposure to Body Fluids

  MAUDE report 20266525 ↗
• MalfunctionOct 17, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THE Y CONNECTOR OF THE SUCTION EVACUATOR WAS DAMAGED. DURING USE, SUCTION WAS NOT APPLIED, AND AIR WAS LEAKING. THE USER ASKED TO CHECK WHETHER THE CONNECTOR HAD A HOLE. AS PER INFORMATION MENTIONED IN THE INTERNAL BD COMMENTS ON (B)(6) 2023, STATED THAT THE CONNECTION BETWEEN THE MAIN UNIT AND THE TUBE WAS LOOSE AND WOBBLY AND SEEMED TO BE COMING OFF. THE Y-SHAPED PART WAS NORMAL, ONE SIDE HAD A HOLE AND THE OTHER SIDE WAS CLOSED. THEY COULD NOT SEE ANY DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948993 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EVACUATOR WAS LEAKING AT THEY PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624514 ↗
• MalfunctionOct 12, 2022Leak/Splash

  DEVICE FOUND LEAKING AT THE Y PORT.

  Patient problems: Insufficient Information

  MAUDE report 15592600 ↗
• MalfunctionSep 2, 2021Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE NEEDLE FELL OFF DURING USE AFTER OPENING THE PACKAGE. WHEN CUSTOMER CHECKED, CUSTOMER FOUND THAT THE TUBE TIP WAS TORN AND HAD BEEN REPAIRED WITH SOME SORT OF CELLOPHANE TAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414974 ↗