inCourage® ICS-1M-US-A (REF R500055-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959420540), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Insufficient Device Problem Information

  THE PATIENT'S DAUGHTER SAYS THAT THE PATIENT IS UNABLE TO TOLERATE THE VEST ANYMORE. THE PATIENT DOESN'T LIKE THE VEST AND HASN'T USED IT FOR SEVERAL MONTHS. THE DOCTOR TOLD THEM THEY CAN RETURN THE DEVICE. THE PATIENT IS VERY TINY, AND THEY FOUND SHE HAS THREE CRACKS IN HER SPINE, UNSURE OF HOW IT HAPPENED. THE PATIENT WAS OFFERED A COMFORT WRAP, BUT THE PATIENT'S DAUGHTER SAID SHE WOULDN'T USE IT.

  Patient problems: Bone Fracture(s)

  MAUDE report 25412491 ↗