Drive DeVilbiss Vacu-Aide Suction Unit 7325P-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885304032564), received between Sep 19, 2022 and Jun 15, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K982304); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "UNIT WILL NOT SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED TO DEVILBISS FOR EVALUATION, WHERE IT WAS DETERMINED THE UNIT WAS UNABLE TO PRODUCE VACUUM PRESSURE TO SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134912 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] VERY LOW SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED TO DEVILBISS FOR EVALUATION, WHERE IT WAS DETERMINED THE UNIT WAS UNABLE TO PRODUCE VACUUM PRESSURE TO SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134098 ↗
• MalfunctionApr 14, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THAT THE "UNIT HAS NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED TO DEVILBISS FOR EVALUATION, WHERE IT WAS DETERMINED THE UNIT WAS UNABLE TO PRODUCE VACUUM PRESSURE TO THE MINIMUM SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742985 ↗
• MalfunctionSep 19, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO REPORTED THAT THE UNIT "QUIT SUCTIONING, AND THE BATTERY LIGHT IS ON, HOWEVER, THERE IS NO SUCTIONING AND NO SOUNDS." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS DISCARDED AND COULD NOT BE EVALUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982304. One submission often covers many models, so check the product and lot details in each record.

• Z-2246-2016 · May 23, 2016 · Terminated
  DeVilbiss Model 7305P-D Powered Suction Unit
• Z-2319-2013 · Mar 7, 2013 · Terminated
  DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container
• Z-0863-2009 · Oct 27, 2008 · Terminated
  DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.