DeVilbiss 7305D-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885304002338), received between Aug 2, 2022 and Sep 20, 2022 — classified as 2 malfunctions.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO REPORTED THAT THE UNIT IS "NOT SUCTIONING." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION. THE ROOT CAUSE OF THE LOW SUCTION CONDITION WAS AN UMBRELLA CHECK VALVE DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH UMBRELLA VALVE COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454473 ↗
• MalfunctionAug 2, 2022Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE RECEIVED A COMPLAINT OF "LOW PRESSURE" INVOLVING A SUCTION UNIT. THERE IS NO REPORT OF INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION. THE ROOT CAUSE OF THE LOW SUCTION CONDITION WAS THE UMBRELLA VALVE HAVING DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH THE VALVE/CYLINDER COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148303 ↗

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.