Simulus™ 800SR28Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169182226), received between Feb 20, 2017 and Sep 4, 2025 — classified as 29 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 reports).

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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 7 MONTHS POST IMPLANT OF THIS SIMULUS SR HEART RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22961923 ↗
• InjuryApr 24, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 10 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH SYMPTOMS OF DYSPNEA AND FLUID OVERLOAD. IT WAS FURTHER DISCOVERED ON EXAMINATION THAT THE PATIENT HAD SEVERE MITRAL REGURGITATION. THE PATIENT WAS ADMITTED, AND MEDICATION WAS ADMINISTERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation; Pulmonary Edema

  MAUDE report 21905681 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 2 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19537602 ↗
• InjuryJul 1, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 32MM MITRAL ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE SURGEONS DECISION TO USE A VALVE OF LARGER SIZE DURING THE REPAIR OF THE PATIENT'S NATIVE MITRAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14883371 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. IT WAS REPORTED AS THE PATIENT'S ANATOMY "DID NOT ALLOW FOR A GOOD REPAIR WITH THE RING". IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH THE PRODUCT ITSELF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12131366 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. IT WAS REPORTED THAT THE ANATOMICAL ORIENTATION OF THE PATIENT'S HEART MADE THE ATTEMPTED VALVE REPAIR CHALLENGING. A RING WAS USED TO AID IN THE REPAIR, BUT TESTING REVELATED RESIDUAL SEVERE LEAK AND "OVERRIDE" OF THE ANTERIOR LEAFLET. THE SURGEON DECIDED THAT A COMPLETE VALVE REPAIR WOULD BE BETTER FOR THE PATIENT. THE ANNULOPLASTY PRODUCT ITSELF DID NOT MALFUNCTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11810582 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28 MM MITRAL ANNULOPLASTY BAND, 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11056783 ↗
• InjuryOct 8, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 26MM ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 10648497 ↗
• InjurySep 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31 MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10609868 ↗
• InjuryMar 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 9860319 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9665196 ↗
• InjuryJan 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 63MM POSTERIOR ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 9611266 ↗
• InjuryJan 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 9558743 ↗
• InjuryJun 26, 2019Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8737193 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE DUE TO INCOMPLETE COAPTATION AND RESIDUAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8678592 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED. THE REASON FOR REPLACEMENT AND THE REPLACEMENT PRODUCT ARE UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8518762 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS AND TWO MONTHS POST IMPLANT OF THIS 28MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 27MM ANNULOPLASTY BAND. THE REASON FOR REPLACEMENT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 8293781 ↗
• InjuryDec 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 26MM RING OF THE SAME MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8126534 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Mitral Regurgitation; No Information

  MAUDE report 8038074 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Code Available; No Information

  MAUDE report 7745706 ↗
• InjuryJul 9, 2018Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER IMPLANTING THIS 28MM ANNULOPLASTY RING IN THE MITRAL POSITION, THE RING WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE PHYSICIAN INDICATED THE VALVE COULD NOT BE REPAIRED AND HAD TO BE REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7672079 ↗
• InjuryFeb 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 32 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 28MM MITRAL ANNULOPLASTY RING FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IMMEDIATELY POST IMPLANT OF THE 28MM MITRAL ANNULOPLASTY RING IT WAS EXPLANTED AND REPLACED. AFTER SUTURING THE RING DOWN SECURELY, TESTING DEMONSTRATED SIGNIFICANT CENTRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7280485 ↗
• InjuryJan 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROS THETIC VALVE. THERE WAS NO ALLEGATION AGAINST THE RING, THE PHYSICIAN DECIDED A VALVE WOULD BETTER REPAIR THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7230774 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE DUE TO SEVERE MITRAL REGURGITATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7121156 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 40 DAYS POST IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE AS IT DID NOT REPAIR THE ISSUE. THE PHYSICIAN REPORTED THE RING WAS FULLY FUNCTIONAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7029448 ↗