SimuForm™ 7800RR28 (UDI 00763000271480)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000271480), received between Feb 24, 2025 and Dec 17, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23826162 ↗
• InjuryJul 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT, AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN DISCOVERED SMALL HYPODENSITIES IN THE RIGHT FRONTOPARIETAL CORTEX AND THE RIGHT BASAL GANGLIA, LIKELY AGE INDETERMINATE INFARCTIONS. IT WAS ALSO REPORTED THAT THE EVENT IS POSSIBLY RELATED TO THE PATIENTS ENDOCARDITIS. IT WAS FURTHER REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. SUBSEQUENTLY, OVER A MONTH LATER, THE ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Stroke/CVA

  MAUDE report 22613613 ↗
• InjuryFeb 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21447194 ↗