Closed Wound Suction 0070850Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741049613), received between Apr 12, 2017 and Dec 12, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THERE WAS NO NEGATIVE PRESSURE ON THE RELIAVAC EVACUATOR AND THE CUSTOMER REFRAINED FROM USING IT IN THE PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981759 ↗
• MalfunctionDec 7, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT NEGATIVE PRESSURE WAS UNABLE TO BE APPLIED IN THE EVACUATOR, SO THE USER REFRAINED FROM USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954666 ↗
• MalfunctionNov 7, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THERE WAS NO SUCTION PRESSURE IN THE RELIAVAC EVACUATOR AND THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762390 ↗
• MalfunctionNov 7, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THERE WAS NO SUCTION PRESSURE IN THE RELIAVAC EVACUATOR AND THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762018 ↗
• MalfunctionJul 28, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE EVACUATOR WAS DIFFICULT TO SUCTION DUE TO NO NEGATIVE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240831 ↗
• MalfunctionMay 10, 2021Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT PARTS OF THE EVACUATOR DEVICE WERE MISSING. SO IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802953 ↗
• MalfunctionNov 30, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CAP OF THE PORT B IN SUCTION EVACUATOR WAS MISSING WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Patient Involvement

  MAUDE report 10920096 ↗
• MalfunctionJan 31, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WERE SOME BLACK COLORED DOTS NOTED INSIDE OF THE DEVICE PRIOR TO USE.

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

  MAUDE report 7232015 ↗
• MalfunctionJan 31, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE USER FOUND, WHAT APPEARED TO BE OIL, INSIDE THE SUCTION DEVICE AFTER HE/SHE OPENED THE PACKAGE.

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

  MAUDE report 7231359 ↗
• MalfunctionApr 13, 2017Aspiration Issue

  IT WAS REPORTED THAT THE SUCTION EVACUATOR WOULD NOT ASPIRATE BODY FLUID AS THE USER APPLIED NEGATIVE PRESSURE TO IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6490459 ↗
• MalfunctionApr 12, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE USER IDENTIFIED FOREIGN MATERIAL ON THE DEVICE. THE FOREIGN MATERIAL ALLEGEDLY APPEARED TO RESEMBLE MOLD, AND WAS ATTACHED INSIDE OF THE SUCTION EVACUATOR. THE FOREIGN MATERIAL WAS IDENTIFIED AS THE USER ATTEMPTED TO USE THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6487683 ↗