DeVilbiss 7305P-D-EXFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885304008873), received between Nov 28, 2022 and Dec 15, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT "WOULD NOT PROVIDE 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 DETERMINED TO BE A BACK SUCTION OF FLUID INTO THE MOTOR OF THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986765 ↗
• MalfunctionNov 28, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. THE ROOT CAUSE WAS DETERMINED TO BE AN UMBRELLA-STYLE CHECK VALVE THAT HAD DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH VALVE/CYLINDER COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868761 ↗
• MalfunctionNov 28, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. THE ROOT CAUSE WAS DETERMINED TO BE AN UMBRELLA-STYLE CHECK VALVE THAT HAD DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH VALVE/CYLINDER COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868614 ↗

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.