inCourage® ICS-1M-US-A (REF R500055-011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959420571), received between Mar 26, 2026 and Mar 26, 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.

• InjuryMar 26, 2026Insufficient Device Problem Information

  THE PATIENT LEFT A VOICEMAIL, REPORTS IN FALL/AUTUMN (2025) AS SHE WAS INCREASING PRESSURE SHE HAD RIB PAIN AND BACKED OFF THE PRESSURE. STATES SHE BROKE HER RIBS BUT WAS NOT AWARE AT THE TIME. SAYS DOES NOT HAVE OSTEOPOROSIS BUT HER BODY REACTS LIKE SHE DOES. CT SCAN ON (B)(6) 2026 SHOWS MULTIPLE RIB FRACTURES ON RIGHT SIDE, KNOWS SHE DIDN'T FALL. ONLY TIME SHE HAD PAIN WAS WHEN SHE WAS INCREASING PRESSURE ON VEST. WANTS US TO CALL BACK IF WE NEED TO OR PUT THAT INFORMATION IN HER FILE.

  Patient problems: Bone Fracture(s)

  MAUDE report 24700456 ↗