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Evacuator 0034830Recalls & reported problems

C. R. Bard, Inc. · ReliaVac 400 Evacuator, 400cc Evacuator · Class 1 · Implant

All models of Evacuator (2)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741049231), received between Jun 6, 2018 and Jun 6, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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

Device problems

  • Break1
  • Detachment Of Device Component1

Patient problems

  • Foreign Body In Patient1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 6, 2018Break; Detachment Of Device Component

    IT WAS REPORTED THAT A PIECE OF THE WOUND DRAIN BROKE OFF WITHIN THE PATIENT'S KNEE. THE PATIENT REQUIRED ADDITIONAL SURGERY TO REMOVE THE BROKEN PIECE. IT WAS LATER REPORTED THAT ONE OF THE DRAIN HOLES OF THE WOUND DRAIN WAS CAUGHT BY ONE OF THE SUTURES IN THE PATIENT'S KNEE, WHICH LED TO THE DEVICE BREAKING UPON REMOVAL.

    Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

    MAUDE report 7575484 ↗

Other APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices

All APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices →

Sources and updates

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