InnovaMatrix AC IMX-0404-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850002643169), received between Apr 23, 2026 and Apr 23, 2026 — classified as 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 18, 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.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CONVATEC POST-MARKET DFU RCT CLINICAL STUDY (B)(4), THAT A 56-YEAR-OLD MALE PATIENT (SUBJECT#: (B)(6) WITH A MEDICAL HISTORY OF TYPE 2 DIABETES MELLITUS, HYPERCHOLESTEROLEMIA, HYPERTENSION, DIABETIC POLYNEUROPATHY, AND DIABETIC FOOT ULCER RECEIVED 8 WEEKLY APPLICATIONS OF INNOVAMATRIX AC WITH THE FIRST APPLICATION ON (B)(6) 2026 AND THE LAST ON (B)(6) 2026. THE SUBJECT BEGAN HAVING PAIN IN THE LEFT FOOT ON (B)(6) 2026 AND WAS HOSPITALIZED ON (B)(6) 2026 WITH A SUSPECTED CELLULITIS. DURING THE HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH A VITAMIN B12 DEFICIENCY. BOTH THE CELLULITIS AND VITAMIN B DEFICIENCY WERE CONSIDERED ADVERSE EVENTS BUT UNRELATED TO THE STUDY DEVICE (INNOVAMATRIX AC) PER THE SITE INVESTIGATOR. THIS CELLULITIS AND HOSPITALIZATION WERE PRIOR TO THE REPORTED SAE DETAILED BELOW FROM THE SITE INVESTIGATOR. ON (B)(6) 2026, THE SUBJECT WAS HOSPITALIZED AGAIN (SEE PRIOR HOSPITALIZATION DETAILS ABOVE) AFTER EXPERIENCING SWELLING AND REDNESS IN HIS LEFT LEG. THE INITIAL DIAGNOSIS WAS A LEFT MID-FOOT PLANTAR WOUND INFECTION AT THE STUDY TREATMENT SITE. THE HOSPITAL DISCHARGE SUMMARY REPORTS THE FOLLOWING DIAGNOSIS: BACTEREMIA, CHRONIC KIDN

  Patient problems: Unspecified Infection

  MAUDE report 24973437 ↗