Evacuator 0070800Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00801741049606), received between Mar 31, 2017 and Jul 10, 2023 — classified as 124 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (52 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 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE RELIAIVAC EVACUATOR BALLOON INSIDE WAS NOT INFLATED AND NEGATIVE PRESSURE WAS NOT APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288629 ↗
• MalfunctionJul 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A HAIR FOUND AND THE SAMPLE WAS DISCARDED AT THE FACILITY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256637 ↗
• MalfunctionJul 30, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE AIR LEAKED FROM THEY CONNECTOR PART OF THE RELIAVAC EVACUATOR ON THE 14TH DAY AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256632 ↗
• MalfunctionJul 16, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RELIAVAC EVACUATOR WAS UNABLE TO SUCTION ONE DAY AFTER THE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181408 ↗
• MalfunctionJul 16, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE EVACUATOR WAS DIFFICULT TO INFLATE DURING THE PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181249 ↗
• MalfunctionJul 15, 2021Inflation Problem; Suction Failure; Inflation Problem; Suction Failure

  IT WAS REPORTED THAT EVACUATOR PRODUCING NO PRESSURE AND THE WASTE FLUID WAS UNABLE TO DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12175027 ↗
• MalfunctionJun 29, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE DRAIN PORT DIDN'T INFLATE AND THERE WAS NO PRESSURE OBSERVED WHEN THE WASTE FLUID WAS SUCTIONED ON THE NEXT DAY AFTER PLACEMENT. THE USER FOUND THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084598 ↗
• MalfunctionJun 16, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THERE WAS NO PRESSURE IN THE RELIAVAC EVACUATOR DURING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009649 ↗
• MalfunctionMay 18, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RELIAVAC EVACUATOR WAS UNABLE TO SUCTION THE PATIENT'S BLOOD DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845867 ↗
• MalfunctionMay 12, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RELIAIVAC EVACUATOR WAS NOT CREATING NEGATIVE PRESSURE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815933 ↗
• MalfunctionApr 14, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT RELIAVAC EVACUATOR WAS UNABLE TO SUCTION DUE TO THE BALLOON DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665350 ↗
• MalfunctionApr 2, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT BALLOON OF THE RELIAVAC EVACUATOR WAS DIFFICULT TO INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607743 ↗
• MalfunctionMar 29, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE RELIAVAC EVACUATOR BALLOON RUPTURED DURING SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582744 ↗
• MalfunctionFeb 25, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO INFLATE WHEN THE DEVICE WAS USED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 08FEB21, THE DEVICE WAS UNABLE TO INFLATE BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11378277 ↗
• MalfunctionFeb 23, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE EXTERIOR PAINT HAD LIQUID IN IT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2021, THE LIQUID WAS INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11366882 ↗
• MalfunctionFeb 22, 2021Gas/Air Leak; Suction Failure; Gas/Air Leak; Suction Failure

  IT WAS REPORTED THAT THE AIR LEAKED DURING THE SUCTION ON THE 3RD DAY AFTER USE.

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

  MAUDE report 11363043 ↗
• MalfunctionJan 19, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE RELIAIVAC EVACUATOR DEVICE WAS DIFFICULT TO ASPIRATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11198498 ↗
• MalfunctionJan 5, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON DIFFICULT TO INFLATE EVEN AFTER APPLYING THE NEGATIVE PRESSURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 11118328 ↗
• MalfunctionDec 30, 2020Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  IT WAS REPORTED THAT THE EVACUATOR RUPTURED ON THE 3RD DAY OF USE. THE PATIENT HEARD A RUPTURE SOUND.

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

  MAUDE report 11098301 ↗
• MalfunctionDec 4, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE EVACUATOR BALLOON WAS DIFFICULT TO INFLATE DURING A PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10949878 ↗
• MalfunctionNov 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON THE NEXT DAY AFTER USE, THE BALLOON GOT TORN.

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

  MAUDE report 10769937 ↗
• MalfunctionOct 26, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE EVACUATOR DIFFICULT TO INFLATE THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734403 ↗
• MalfunctionSep 21, 2020Crack; Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A CRACK INSIDE THE BOTTLE.

  Patient problems: Insufficient Information; No Patient Involvement

  MAUDE report 10560962 ↗
• MalfunctionSep 18, 2020Incorrect Measurement; Material Rupture; Incorrect Measurement

  IT WAS REPORTED THAT THE BALLOON BURST ON THE 6TH DAY OF USE. PER ADDITIONAL INFORMATION RECEIVED FROM IBC VIA MAIL ON 02SEP2020, THE BALLOON BURST IN THE BOTTLE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10553065 ↗
• MalfunctionSep 17, 2020Inflation Problem

  IT WAS REPORTED THAT THE RELIAVAC EVACUATOR WAS DIFFICULT TO INFLATE DURING PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10546832 ↗