SimuPlus™ 7700FB32 (UDI 00763000271312)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000271312), received between Jun 22, 2022 and Jun 5, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25407671 ↗
• InjuryMay 12, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 4 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC M ITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25146541 ↗
• InjuryNov 24, 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 32MM MITRAL ANNULOPLASTY BAND IT WAS EXPLANTED AND REPLACED WITH 30MM MITRAL ANNULOPLASTY HEART BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23629518 ↗
• InjuryJul 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS TRI-AD TRICUSPID HEART BAND AND SIMUPLUS MITRAL HEART BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS AV BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22574014 ↗
• InjuryJul 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 32MM BAND 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 22382764 ↗
• InjuryFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS A FAILED REPAIR THAT NEEDED TO BE CONVERTED TO A FULL REPLACEMENT. IT WAS FURTHER REPORTED THAT THE DEVICE DID NOT MALFUNCTION, AND THE ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21409488 ↗
• InjuryJan 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM 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

  MAUDE report 21062813 ↗
• InjuryOct 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THESE 34MM AND 32MM MITRAL ANNULOPLASTY BANDS, THEY WERE EXPLANTED AND ULTIMATELY REPLACED WITH A 32MM ANNULOPLASTY BAND 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 20491436 ↗
• InjuryMar 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS FURTHER REPORTED THAT THIS 30MM MITRAL ANNULOPLASTY BAND WAS ALSO EXPLANTED DURING THE SAME PROCEDURE AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THIS REPLACEMENT WAS ALSO NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18847449 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT HAD ATRIAL FLUTTER. IT WAS ALSO REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED ATRIAL FLUTTER WITH VARIABLE ATRIO-VENTRICULAR BLOCK (AV BLOCK). APPROXIMATELY 22 DAYS LATER, A FOLLOW-UP APPOINTMENT ECHO DISCOVERED SINUS BRADYCARDIA WITH 1ST DEGREE AV BLOCK. CARDIOVERSION WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18619645 ↗
• InjuryNov 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, THE PATIENT WENT IN TO ATRIAL FIBRILLATION (AFIB) WITH RAPID VENTRICULAR RESPONSE (RVR) DURING THE NIGHT AND WAS STARTED ON A ANTI-ARRHYTHMIC INTRAVENOUS (IV) MEDICATION AND RETURNED TO NORMAL SINUS RHYTHM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 18065708 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE 32MM MITRAL ANNULOPLASTY BAND WAS NOT EXPLANTED 9 DAYS POST IMPLANT AND REMAINS IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17859474 ↗
• InjuryAug 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE 32MM MITRAL ANNULOPLASTY BAND IS STILL IMPLANTED AND ACTIVE IN THE PATIENT. THERE WAS NO ALLEGATION AGAINST THE ANNULOPLASTY PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 17609937 ↗
• InjuryNov 8, 2022Inadequacy 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 2 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A BAND OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A SIZING ISSUE. IT WAS REPORTED THAT THE PHYSICIAN HAD THOUGHT THAT THE BAND WAS UNDERSIZED FOR THE PATIENT. IT WAS INDICATED THAT WHEN THE BAND WAS REMOVED AND THE ANNULUS WAS REMEASURED, IT WAS OBSERVED THAT THE SELECTED SIZE HAD BEEN CORRECT. IT WAS STATED THAT IT WAS INITIALLY THOUGHT TO BE THE INCORRECT SIZE DUE TO AN ERROR IN THE SUTURE TECHNIQUE. IT WAS MENTIONED THAT THERE WAS NO ISSUE WITH THE BAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15752999 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION AND CARDIAC ARREST. IT WAS ALSO REPORTED THAT A REOPERATION (MEDIASTINAL EXPLORATION) WAS PERFORMED AND THE PATIENT WAS DEFIBRILLATED UNTIL THE RETURN OF SPONTANEOUS RHYTHM AND BLOOD PRESSURE. IT WAS REPORTED THAT DURING THE MEDIASTINAL EXPLORATION PROCEDURE, THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND CARDIOVERSION WAS PERFORMED WHICH RESOLVED THE ATRIAL FIBRILLATION. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED POST RE-OPERATION NOTED DECREASED RIGHT VENTRICULAR FUNCTION, ADEQUATE LEFT VENTRICULAR FUNCTION AND NO MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 14777285 ↗