The Vest APX System M08463Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887761967243), received between May 29, 2026 and Sep 18, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 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.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumonia

  MAUDE report 50830363 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED EATING DIFFICULTIES WHICH PREVENT THE PATIENT FROM HOLDING DOWN FOOD AFTER USING THE VEST APX DEVICE SYSTEM. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO EATING DIFFICULTIES AND DISCHARGED, THE EXACT DATE IS UNKNOWN. SHORTLY AFTER THIS EVENT THE PATIENT WAS ADMITTED AGAIN IN THE HOSPITAL FOR EATING DIFFICULTIES, APPROXIMATELY 10 DAYS WHERE SHE WAS DIAGNOSED WITH THIRD HIATAL HERNIA, AS WELL AS ESOPHAGEAL THICKENING, AND NARROWED ESOPHAGUS CAUSED BY THE HERNIA¿S SHIFT WHICH REQUIRED MEDICAL TREATMENT (HOSPITALIZATION, ESOPHAGOGASTRODUODENOSCOPY, BALLOON DILATION, DIETARY RESTRICTIONS). THE PATIENT IS AWAITING AN ADDITIONAL PROCEDURE TO CORRECT THE CONDITION. PATIENT HAS NOT USED THE VEST AIRWAY CLEARANCE DEVICE FOR OVER 90 DAYS AFTER THE EVENTS. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE DEVICE IS BEING RETURNED DUE TO THE PATIENT¿S DISCONTINUANCE OF DEVICE THERAPY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hernia

  MAUDE report 25385703 ↗
• MalfunctionMay 29, 2026Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT THAT VEST APX SYSTEM NEW DEVICE HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337379 ↗