Simulus™ 800SC24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169182202), received between Nov 17, 2021 and Feb 28, 2024 — 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.

• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 24MM MITRAL ANNULOPLASTY BAND AND 28MM TRICUSPID ANNULOPLASTY BAND, THE PATIENT WAS HOSPITALIZED AND HAD WOUND VAC APPLIED TO THEIR LEFT GROIN. ANTIBIOTICS WERE ADMINISTERED. IT WAS STATED THAT THE EVENT WAS POSSIBLY RELATED TO THE SURGICAL PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18795801 ↗
• InjuryFeb 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 24MM MITRAL ANNULOPLASTY BAND AND 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS DISCHARGED 8 DAYS LATER AND 2 DAYS FOLLOWING DISCHARGE, THE PATIENT WAS HOSPITALIZED AGAIN FOR ALMOST A MONTH. THE REASON FOR HOSPITALIZATION WAS NOT REPORTED. IT WAS STATED THAT THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE IN COMBINATION WITH THE PATIENTS CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18677678 ↗
• InjuryNov 17, 2021Material Separation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Separation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 24MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 25MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Pseudoaneurysm

  MAUDE report 12831544 ↗