Closed Wound Suction 0043620Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741049361), received between Jan 30, 2018 and Sep 10, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Disconnection” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Dull, Blunt

  It was reported that customer had concern in the Operating Room with two evacuators. Also felt the evacuators were dull than in the past. Material 0043610 and Material 0043620.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716248 ↗
• MalfunctionJun 12, 2026Disconnection

  IT WAS REPORTED THAT AT 07:30 THE PATIENTS HEMOVAC DRAIN APPEARED TO NOT BE PRIMED. ATTEMPTED TO PRIME THE HEMOVAC. AFTER ATTEMPTING TO PRIME IT TOOK THE HEMOVAC LESS THAN 2 SECONDS TO COMPLETELY REFILL WITH AIR. WHEN CHECKING THE LINE, THEY FOUND THAT THE DRAIN WAS COMPLETELY DISCONNECTED WITH BOTH ENDS UNDERNEATH THE PATIENT WITH DRAINAGE ON THE PATIENTS BEDDING AND GOWN. THEY THEN APPLIED STERILE GAUZE TO THE END OF THE TUBE AND CLAMPED THE LINE. PATIENT EXPERIENCED UNEXPECTED AND PROLONGED CARE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 25493461 ↗
• MalfunctionJun 11, 2026Disconnection

  IT WAS REPORTED THAT THE HEMOVAC DRAIN WAS DISCONNECTED ON THE PORT WHEN PATIENT MOVED AND HAD THE BLOOD SATURATING THE LINENS.

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

  MAUDE report 25480177 ↗
• MalfunctionMar 24, 2026Disconnection

  IT WAS REPORTED THAT THE PATIENT'S HEMOVAC SURGICAL BACK DRAIN BECAME DISCONNECTED FROM Y-SITE WHEN PATIENT WAS SITTING AT EDGE OF BED. TUBING CLAMPED WITH AND END KEPT STERILE WITH GAUZE. CLEANSED WITH CHLOROHEXADINE BEFORE REATTACHING TO A NEW STERILE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677637 ↗
• MalfunctionMar 2, 2026Disconnection

  IT WAS REPORTED THAT THE PATIENT¿S SURGICAL BACK DRAIN (HEMOVAC) HAD BECOME DISCONNECTED FROM THE Y SITE WHILE THE PATIENT WAS SITTING AT THE EDGE OF THE BED. THE TUBING HAD BEEN CLAMPED, AND THE END HAD BEEN KEPT STERILE WITH GAUZE. THE AREA HAD BEEN CLEANSED WITH CHLORHEXIDINE BEFORE THE TUBING WAS REATTACHED TO A NEW STERILE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478887 ↗
• MalfunctionFeb 8, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT A WOUND SUCTION DEVICE WAS USED TO PATIENT. THE DEVICE WAS COMPRESSED BUT DID NOT STAY THAT WAY. IT KEPT FILLING WITH AIR AND THERE WERE NO HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666905 ↗
• MalfunctionNov 20, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE HEMOVAC DRAIN TUBING HAD NO SECURING FEATURE WHERE THE TUBES CONNECTED AT THE Y-SITE. MULTIPLE PATIENTS HAD DISCONNECTION IN UNSTERILE SETTING CAUSING RISK FOR INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169442 ↗
• MalfunctionJul 28, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT HAD A DAVOL CLOSED WOUND SUCTION EVACUATOR DRAIN IN SITU TO BACK. IT WAS STATED THAT THE RESERVOIR WAS CLIPPED TO THE FITTED SHEET OF THE BED. THE PATIENT WAS TAKEN DOWN FOR TRANSPORT TO THE X-RAY DEPARTMENT. UPON RETURN TO THE UNIT, IT WAS NOTED THAT THE TUBING HAD BECOME DISCONNECTED (UNWITNESSED) AT THE JUNCTION BETWEEN THE PATIENT SIDE AND RESERVOIR SIDE. IT WAS ALSO NOTED THAT NO SERIOUS HARM WAS REPORTED. UNFORTUNATELY, THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413715 ↗
• MalfunctionOct 26, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE NEW ¼ INCH HEMOVAC EVACUATOR HAD A FAULTY DRAIN INSERT FOR THE DRAIN TO THE 400 ML RESERVOIR. IT WAS ALSO STATED THAT THE DEVICE FELL OUT AND CAUSED POSSIBLE CONTAMINATION OF THE DRAIN ON THE OPERATIVE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698141 ↗
• MalfunctionJul 8, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THERE HAD BEEN 4 INSTANCES REPORTED BY STAFF THAT HEMOVACS DISCONNECTED WHILE MANEUVERING PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134664 ↗
• MalfunctionJul 7, 2021Disconnection; Disconnection

  IT WAS REPORTED BY THE STAFF THAT THERE WERE 4 INSTANCES OF THE HEMOVACS GETTING DISCONNECTED WHILE MANEUVERING PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128889 ↗
• MalfunctionJun 3, 2021Disconnection

  THERE HAVE BEEN 4 INSTANCES REPORTED BY STAFF OF THE HEMOVACS DISCONNECTING WHILE MANEUVERING PATIENTS.

  Patient problems: Insufficient Information

  MAUDE report 11929737 ↗
• InjuryMar 19, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE WOUND DRAIN WAS PLACED DURING A LUMBAR SURGERY ON (B)(6) 2017 AND AN APPROXIMATE 4 INCH PIECE OF THE TUBING BROKE OFF WHILE THE SURGEON WAS REMOVING THE DRAIN THE MORNING OF (B)(6) 2017. THE PATIENT REPORTEDLY RETURNED TO SURGERY ON (B)(6) 2017 TO HAVE THE RETAINED PIECE OF THE TUBING REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7349338 ↗
• MalfunctionJan 30, 2018Cut In Material

  IT WAS REPORTED THAT CUTS WERE FOUND ALONG THE TUBING OF THE EVACUATOR; WHICH CAUSED THE DEVICE NOT TO DRAIN PROPERLY. THE CUTS WERE FOUND WHILE LARGE AMOUNTS OF BLOOD WERE BEING DRAINED. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7228280 ↗
• MalfunctionJan 30, 2018Disconnection

  IT WAS REPORTED THAT THE DEVICE DISCONNECTED AT THE Y-SITE. THE DISCONNECT OCCURRED DURING THE DRAINING OF LARGE AMOUNTS OF BLOOD. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7228248 ↗
• MalfunctionJan 30, 2018Disconnection

  IT WAS REPORTED THAT THE DEVICE DISCONNECTED AT THE Y-SITE. THE DISCONNECT OCCURRED DURING THE DRAINING OF LARGE AMOUNTS OF BLOOD. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7228244 ↗
• MalfunctionJan 30, 2018Disconnection

  IT WAS REPORTED THAT THE DEVICE DISCONNECTED AT THE Y-SITE. THE DISCONNECT OCCURRED DURING THE DRAINING OF LARGE AMOUNTS OF BLOOD. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7228120 ↗