SimuForm™ 7800RR36 (UDI 00763000271527)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000271527), received between Sep 23, 2024 and Jul 15, 2026 — classified as 3 injuries.

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.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 36MM MITRAL ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25822703 ↗
• InjuryNov 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, TRIVIAL TO MILD MITRAL REGURGITATION WAS OBSERVED. IT WAS FURTHER INDICATED THAT DURING THE IMPLANT OF THE 36MM TRICUSPID ANNULOPLASTY R ING, IT WAS EXPLANTED AND REPLACED WITH A 34MM BAND OF A DIFFERENT MANUFACTURER. IT WAS ALSO REPORTED THAT POST IMPLANT OF THE MITRAL DEVICE, A HEMOTHORAX WAS DISCOVERED. A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WAS PERFORMED TO REMOVE THE HEMOTHORAX. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemothorax; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20604187 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT HAD A LEFT HEMOTHORAX. IT WAS FURTHER NOTED THAT A LARGE HEMATOMA AT THE APEX OF THE HEMITHORAX WAS DISCOVERED ALONG WITH A FAIR AMOUNT OF SANGUINEOUS FLUID. ASPIRATION WAS PERFORMED TO EVACUATE THE CLOT AND FLUID. 500CC OF ANTIBIOTIC WATER WAS INSTILLED. APPROXIMATELY 1 LITER OF CLOT AND BLOOD WAS EVACUATED. NO EVIDENCE OF ACTIVE BLEEDING WAS NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Hemothorax

  MAUDE report 20286840 ↗