Closed Wound Suction 0043660Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741049392), received between Feb 16, 2018 and Jun 13, 2023 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WOUND DRAIN WAS NOT CLINICALLY ACCEPTABLE, PROVIDERS FELT IT WAS TOO FLIMSY AND HAD THE POTENTIAL TO BREAKING OFF. ALSO STATED THAT THIS HAD HAPPENED IN THE PAST WHERE DURING PHYSICAL THERAPY IT GOT CAUGHT ON THE PATELLA AND SNAPPED OFF CAUSING THE PATIENT TO HAVE TO RETURN FOR SURGERY TO HAVE THE LOST PIECE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17119520 ↗
• MalfunctionFeb 10, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SUCTION EVACUATOR GOT BROKEN WHEN THE USER TRIED TO INSTALL THEM ON PATIENTS. THEREFORE, THE CUSTOMER WANTED TO RETURN (B)(4) UNITS. PER MAIL RECEIVED FROM IBC ON 20FEB2023, STATED THAT THEY ORDERED THE PRODUCT IN 2021, 60 UNITS WERE ORDERED, AND THEY WANTED TO RETURN (B)(4) UNITS WITH AN EXPIRATION DATE OF MARCH 31, 2026. THEY CUSTOMER RECEIVED COMPLAINTS THAT THE PRODUCT BROKE DURING INSTALLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352050 ↗
• MalfunctionJun 24, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TUBE IN THE EVACUATOR WAS PERFORATED AND WAS VERY EASY TO BREAK WHEN PUT AT KNEE LEVEL. THERE WAS A RISK TO LEAVE A PIECE WHEN REMOVE OUT OF THE KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12057640 ↗
• MalfunctionJun 11, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT CLOSED WOUND SUCTION KIT WAS FALLING APART AT THE POINT WHERE THE TUBING STICK INTO THE ACCORDION DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986396 ↗
• InjuryMar 17, 2020Break

  IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE DRAIN FROM THE PATIENT'S LEFT BUTTOCK, THE DRAIN TUBING BROKE. THE TUBING REMAINED INSIDE OF THE PATIENT. AND ADDITIONAL SURGERY WAS SCHEDULED FOR REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 9841630 ↗
• MalfunctionMay 22, 2019Disconnection

  IT WAS REPORTED THAT THE HEMOVAC WOUND DRAIN TUBING DISCONNECTED FROM THE DEVICE. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 8630676 ↗
• MalfunctionMay 22, 2019Disconnection

  IT WAS REPORTED THAT THE HEMOVAC WOUND DRAIN TUBING DISCONNECTED FROM THE DEVICE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8630673 ↗
• MalfunctionMay 22, 2019Disconnection

  IT WAS REPORTED THAT THE HEMOVAC WOUND DRAIN TUBING DISCONNECTED FROM THE DEVICE. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 8630671 ↗
• MalfunctionApr 17, 2019Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM THE HEMOVAC DRAIN.

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

  MAUDE report 8525235 ↗
• MalfunctionFeb 16, 2018Disconnection

  IT WAS REPORTED THAT THE EVACUATOR TUBING DISCONNECTED "NEAR THE CLAW." NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7276253 ↗