The Vest®System P105BTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887761997769), received between Jun 12, 2025 and Apr 20, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT THAT CONTROLLER,VEST 105,BT HAD POWER CORD DAMAGED WITH COPPER WIRE 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 24933773 ↗
• MalfunctionJan 29, 2026Material Split, Cut or Torn

  ON (B)(6) 2026, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT CONTROLLER, VEST 105, BT (PRODUCT CODE P105BYWAR, SERIAL NUMBER (B)(6)), 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 24214530 ↗
• MalfunctionJan 13, 2026Sparking

  ON 19-DEC-2025, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT CONTROLLER, VEST 105, BT (PRODUCT CODE P105BYWAR, SERIAL NUMBER (B)(6)), WHEN THEY PLUGGED THE DEVICE INTO THE WALL OUTLET, THERE WAS A VISIBLE SPARK, CUT THE BREAKER IN THE HOUSE. THERE ARE NO VISIBLE BREAKS IN THE POWER CORD ON EITHER END UPON INSPECTION. THIS OCCURRED AT HOME BEFORE USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063609 ↗
• MalfunctionJun 12, 2025Sparking; Material Split, Cut or Torn; Sparking; Material Split, Cut or Torn

  IT WAS REPORTED WHEN PLUGGED POWER CORD IN, IT SPARKED. ADDITIONALLY, CUSTOMER NOTED COPPER WIRES WERE EXPOSED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195848 ↗