The Vest®System 105000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761997752), received between Nov 14, 2024 and Jul 14, 2025 — classified as 1 injury, 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. 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.

• MalfunctionJul 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE VEST MODEL 105 SERVICED POWER CORD HAD COPPER WIRES EXPOSED. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500572 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LUNG PAIN COINCIDENT WITH USE OF THE VEST THERAPY DEVICE WITH THE C3 GARMENT. IT IS NOTED THE PATIENT ATTEMPTED TO LOWER DEVICE THERAPY SETTINGS, BUT PAIN WITH USE DID NOT RESOLVE. THE PATIENT NOTIFIED HER HEALTHCARE PROVIDER AND WAS PRESCRIBED AN ANTIBIOTIC. IT IS NOTED THE PATIENT DID NOT KNOW THE DIAGNOSIS RELATED TO THE ORDERED ANTIBIOTIC. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION, HOWEVER, THE PATIENT FEELS THE VEST DEVICE WAS NOT WORKING AND IS RETURNING THE DEVICE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Pain

  MAUDE report 20688160 ↗