Closed Wound Suction 0070900Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741049620), received between Apr 24, 2017 and Jan 31, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 31, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT SUCTION EVACUATOR WAS NOT POSSIBLE TO ASPIRATE BECAUSE NEGATIVE PRESSURE WAS NOT APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271811 ↗
• MalfunctionNov 15, 2020Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON THE DAY OF USE THE DRAINAGE PORT CAP OF THE DEVICE BOTTOM GOT BROKEN.

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

  MAUDE report 10841708 ↗
• MalfunctionJun 24, 2020Material Fragmentation; Break; Material Fragmentation; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EVACUATOR WAS FOUND TO BE BROKEN WHEN THE PACKAGE WAS OPEN. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC REPRESENTATIVE ON 15JUN2020 IT WAS NOTED THAT THE SUCTION PORT WAS BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 10190208 ↗
• MalfunctionJun 14, 2020Disconnection; Disconnection; Difficult to Open or Close

  IT WAS REPORTED THAT THE CAP ON THE RELIAVAC WOUND DRAIN WOULD NOT STAY CLOSED THEREFORE THERE WAS NO SUCTION FROM THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 1 JUNE 2020 FROM IBC REPRESENTATIVE, THE CAP ON THE RELIVAC WOULD NOT STAY CLOSED. SEE PHOTOS ATTACHED.

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

  MAUDE report 10151508 ↗
• MalfunctionAug 30, 2019Disconnection

  IT WAS REPORTED THAT THE DRAINAGE TUBE WAS DISCONNECTED DURING USE.

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

  MAUDE report 8951724 ↗
• MalfunctionAug 7, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE EVACUATOR CAP WAS FOUND TO BE DEFORMED.

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

  MAUDE report 8868919 ↗
• MalfunctionMar 7, 2019Misassembled; Detachment of Device or Device Component; Misassembled

  IT WAS REPORTED THE BLUE CAP WAS NOT ATTACHED TO THE EVACUATOR.

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

  MAUDE report 8400111 ↗
• MalfunctionFeb 6, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CONNECTOR WAS LOOSE AND DID NOT FIT THE DRAIN TUBE.

  Patient problems: No Patient Involvement

  MAUDE report 8311186 ↗
• MalfunctionNov 29, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM THE BULB AND RESULTED IN BLOOD GETTING ON THE PATIENT. THE COMPLAINANT REPORTED THAT THE NURSING STAFF ATTEMPTED TO USE TAPE TO ADHERE THE TUBING TO THE BULB PRIOR TO REPLACING THE PRODUCT.

  Patient problems: No Code Available

  MAUDE report 7068198 ↗
• MalfunctionApr 24, 2017Crack

  IT WAS REPORTED THAT THE USER FOUND A CRACK ON THE JUNCTION OF THE SUCTION EVACUATOR AND THE Y CONNECTOR PRIOR TO USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Information

  MAUDE report 6517472 ↗