EvacuatorRecalls & reported problems across all models

We found 2 models of Evacuator by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 125 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2017 and Jul 10, 2023 — classified as 1 injury, 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Evacuator problems

Evacuator models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Evacuator 0070800

  APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
  124 reports
• Evacuator 0034830

  APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
  1 report

Recent Evacuator adverse event reports

The 15 most recent reports across all models, 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 ↗

Other C. R. Bard, Inc. products

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• Bardex All-Silicone Foley Catheter12 models · 1,170 reports