The Vest®System P205cmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761997431), received between May 20, 2025 and Mar 31, 2026 — classified as 1 death, 1 injury.

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

Recent adverse event reports

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

• DeathMar 31, 2026Adverse Event Without Identified Device or Use Problem

  BAXTER RECEIVED A REPORT THAT A PATIENT PASSED AWAY WHILE USING A VEST 205 THERAPY DEVICE. THE PATIENT WAS HOSPITALIZED AT THE TIME FOR SUSPECTED PNEUMONIA OR VIRAL MENINGITIS. THIS WAS THE PATIENT¿S FIRST USE OF THE DEVICE, AND THERAPY WAS INITIATED BY HOSPITAL STAFF WHO SUBSEQUENTLY LEFT THE ROOM. WITHIN APPROXIMATELY TWO MINUTES, THE PATIENT REPORTEDLY BEGAN VOMITING AND ASPIRATING FLUID, FOLLOWED BY A DECREASE IN HEART RATE. NO HOSPITAL CAREGIVERS WERE PRESENT IN THE ROOM AT THE TIME, AND IT IS UNKNOWN WHETHER ANY LIFE SUSTAINING MEASURES WERE ATTEMPTED. THE PATIENT SUBSEQUENTLY EXPIRED THAT SAME DAY. THE REPORTED CAUSE OF DEATH LISTED AS VIRAL MENINGITIS. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. PER THE INSTRUCTIONS FOR USE STATE THE DEVICE "WE RECOMMEND YOUR FIRST USE OF THIS PRODUCT BE IN A SUPERVISED SETTING SUCH AS A DOCTOR¿S OFFICE OR AT HOME WITH A CLINICAL TRAINER". THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION, AND THE HEALTHCARE FACILITY HAS NOT IDENTIFIED THE SPECIFIC DEVICE INVOLVED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aspiration/Inhalation; Cardiac Arrest; Vomiting

  MAUDE report 24749661 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED A HEPATIC AND SPLENIC LACERATIONS POTENTIALLY IN CONJUNCTION WITH A VEST SYSTEM. WHILE HOSPITALIZED THE PATIENT DEVELOPED ABDOMINAL DISTENSION DUE TO ABDOMINAL COMPARTMENT SYNDROME. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND SPLENIC AND HEPATIC LACERATIONS WERE FOUND. THREE DAYS POST OPERATIVE THE PATIENT UNDERWENT A HEPATIC ARTERY EMBOLIZATION. THREE DAYS LATER, THE ABDOMEN WAS CLOSED. ADDITIONALLY, THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE EXACT CAUSE OF THE SPLENIC AND HEPATIC LACERATIONS IS UNDETERMINED AT THIS TIME AND WERE LIKELY DUE TO THE PATIENT¿S UNDERLYING MEDICAL CONDITIONS. HOWEVER, BASED ON THE LIMITED INFORMATION, IT CANNOT BE EXCLUDED THAT USE OF THE VEST HAD AN INDIRECT CONTRIBUTORY IMPACT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Laceration(s); Liver Laceration(s)

  MAUDE report 22055305 ↗