Closed Wound Suction 0034600Recalls & reported problems
C. R. Bard, Inc. · ReliaVac 400 Closed Wound Suction Kit, Small 3/32" (7Fr., 2.3mm) O.D. PVC Drain, 12.5" Hole Pattern, X-Ray Opaque Stripe with Attached Trocar, 400cc Evacuator · Class 1 · Implant
All models of Closed Wound Suction (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741049118), received between Mar 29, 2017 and Apr 27, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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
Device problems
- Inflation Problem2
- Suction Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2020Inflation Problem
IT WAS REPORTED THAT THE RELIAVAC WOUND DRAIN WAS DIFFICULT TO INFLATE DURING USE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10001600 ↗MalfunctionDec 27, 2017Suction Problem
IT WAS REPORTED THAT THE SUCTION DEVICE COULD NOT SUCTION AS THE NEGATIVE PRESSURE WAS APPLIED. THIS EVENT OCCURRED BEFORE USE FOR A PATIENT.
Patient problems: No Information
MAUDE report 7147412 ↗MalfunctionMar 29, 2017Inflation Problem
IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE WHEN TRYING TO CREATE NEGATIVE PRESSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6445032 ↗
Other APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices
- Closed Wound Suction 0043610C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED303 reports
- Closed Wound Suction 0070740C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED192 reports
- Evacuator 0070800C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED124 reports
- Closed Wound Suction 0034610C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED62 reports
- CARDINAL HEALTH SU130-402DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall1 report
- CARDINAL HEALTH SU130-403DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- CARDINAL HEALTH SU130-475Cardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- DLP® 10061Medtronic, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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