Simulus™ 800SR38Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169182240), received between Jan 2, 2018 and Mar 10, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE MITRAL REGURGITATION. IT WAS STATED THAT THE PATIENT HAS NO CARDIAC SYMPTOMS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21560574 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 40MM ANNULOPLASTY PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER IMPLANT, SYSTOLIC ANTERIOR MOTION (SAM) OF THE PATIENT'S NATIVE LEAFLETS OCCURRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21453213 ↗
• InjuryFeb 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21443594 ↗
• InjuryNov 15, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT MODERATE MITRAL INSUFFICIENCY WAS OBSERVED ON A TRANSTHORACIC ECHOCARDIOGRAM. IT WAS LATER REPORTED THAT 2 YEARS POST IMPLANT OF THIS RING, THE PATIENT HAD A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WHICH SHOWED MILD MITRAL REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20700388 ↗
• InjuryNov 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 15 DAYS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, ACUTE PLEURAL EFFUSION WAS OBSERVED ON AN ECHOCARDIOGRAM. ONE DAY LATER, A PERCUTANEOUS PUNCTURE WAS PERFORMED. THE SITE ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pleural Effusion

  MAUDE report 20674470 ↗
• InjuryFeb 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 38 MM ANNULOPLASTY RING, IT WAS NOTED ON ELECTROCARDIOGRAM THAT THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND ATRIAL FLUTTER. IT WAS REPORTED THAT MEDICATIONS WERE GIVEN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Non specific EKG/ECG Changes

  MAUDE report 18711915 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 9 MONTHS POST IMPLANT OF THIS 38MM 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 16851678 ↗
• InjuryNov 29, 2022Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, MODERATE TO SEVERE MITRAL REGURGITATION WAS NOTED ON ECHOCARDIOGRAM (ECHO). IT WAS REPORTED THAT TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED NOTED PROLAPSE OF THE POSTERIOR LEAFLET. IT WAS ALSO REPORTED THAT THE PATIENT IS ASYMPTOMATIC AND NO TREATMENT OR INTERVENTION HAS OCCURRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 6 MONTHS LATER, THE 38MM MITRAL ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A NON-MDT PRODUCT. IT WAS ALSO REPORTED THAT AFTER IMPLANT OF THE NON-MDT PRODUCT, THERE WAS MITRAL VALVE REGURGITATION AND ATRIO-VENTRICULAR (AV) JUNCTIONAL RHYTHM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15880223 ↗
• InjuryMar 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 9 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13686265 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 DAYS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. ONE DAY LATER THE PATIENT UNDERWENT A MINIMALLY INVASIVE PROCEDURE WHERE A 2X4CM PORTION OF THE PERICARDIUM WAS REMOVED AND 320ML OF BLOOD WAS EMPTIED FROM THE PERICARDIAL SAC. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 4 DAYS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 13061581 ↗
• InjuryOct 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 11 MONTHS POST IMPLANT OF THIS 38MM 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12700961 ↗
• InjuryJun 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT'S NATIVE MITRAL VALVE HAD REGURGITATION AS A RESULT OF DEGENERATIVE VALVE DISEASE. THE MITRAL VALVE WAS REPAIRED WITH THIS ANNULOPLASTY RING. THE VALVE APPEARED TO BE COMPETENT. PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOW GRADE II INSUFFICIENCY WITH AN ECCENTRIC JET. THE VALVE WAS TESTED WITH WATER, WHICH REVEALED A NEW CHORDAE TENDINEAE RUPTURE. AS A RESULT, THE SURGEON OPTED FOR A COMPLETE VALVE REPLACEMENT, AND THE ANNULOPLASTY RING WAS EXPLANTED TO ACCOMPLISH THIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12031367 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10727444 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS RESIDUAL REGURGITATION. THE PHYSICIAN STATED THAT THERE WERE NO ISSUES WITH THE ANNULOPLASTY RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Mitral Regurgitation

  MAUDE report 8859623 ↗
• InjuryDec 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 36MM RING OF THE SAME MODEL. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8138250 ↗
• InjuryJan 2, 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 AN UNKNOWN DURATION FOLLOWING IMPLANT OF THIS MITRAL RING, IT WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7158164 ↗