SimuPlus™ 7700FB34 (UDI 00763000271329)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000271329), received between Aug 29, 2022 and Apr 8, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 YEARS AND 3 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 38MM MITRAL 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 24815201 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 DAY POST IMPLANT OF THIS 34MM SIMUPLUS ANNULOPLASTY HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDT RONIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24363202 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS RESIDUAL REGURGITATION. THE DEVICE DID NOT MALFUNCTION AND THE DEVICE WAS FULLY SUTERED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23826055 ↗
• InjuryJun 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 34 M ANNULOPLASTY BAND, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 22358833 ↗
• InjuryJan 27, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF THIS 34MM SIMUPLUS MITRAL BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MOSAIC MITRAL 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 21240099 ↗
• InjuryOct 21, 2024Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE 34MM MITRAL ANNULOPLASTY BAND WAS NOT EXPLANTED, AS IT WAS RE-POSITIONED AND TIGHTENED DURING THE PROCEDURE. A 34MM TRICUSPID ANNULOPLASTY BAND WAS IMPLANTED CONCOMITANTLY DURING THIS PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20500134 ↗
• InjurySep 20, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, A 34MM MITRAL ANNULOPLASTY BAND AND A 40MM MITRAL ANNULOPLASTY BAND WERE BOTH ATTEMPTED AND REPLACED WITH A 42MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE REGURGITATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20268568 ↗
• InjuryAug 27, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM 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 20075840 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM 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

  MAUDE report 19809211 ↗
• InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM 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 19793976 ↗
• InjuryJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS REPORTED THAT, "THIS WAS A FAILED REPAIR AND NOT DUE TO THE BAND. HAD TO BE REPLACED." NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19464113 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM (ECG) PERFORMED NOTED PREMATURE ATRIAL COMPLEXES. SUBSEQUENTLY 4 DAYS LATER, A SECOND ECG PERFORMED NOTED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND INCOMPLETE RIGHT BUNDLE BRANCH BLOCK (RBBB). ONE DAY LATER, SINUS BRADYCARDIA WAS NOTED ON ECG. THE CONDUCTION DISTURBANCES PROLONGED HOSPITALIZATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18905327 ↗
• InjuryDec 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM 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

  MAUDE report 18355412 ↗
• InjurySep 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH ACUTE ON SET CHRONIC HEART FAILURE. IT WAS REPORTED THAT 2 DAYS LATER, AFTER A CARDIAC SURGERY CONSULT, DIURETICS WERE ADMINISTERED DUE TO BLOOD VOLUME OVERLOAD AND HEART FAILURE. IT WAS REPORTED THAT 24DAYS LATER, AN ECHOCARDIOGRAM (ECHO) PERFORMED NOTED THICKENED NATIVE MITRAL LEAFLETS WITH RESTRICTED POSTERIOR NATIVE MITRAL VALVE LEAFLET, MODERATE TO SEVERE MITRAL REGURGITATION. (MR) AND MODERATELY DECREASED RIGHT VENTRICLE (RV) SYSTOLIC FUNCTION. ONE DAY LATER, THE 34MM MITRAL ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. IT WAS STATED THAT DURING THE EXPLANT PROCEDURE, THE PATIENT'S TRICUSPID NATIVE VALVE WAS ALSO REPAIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17827452 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 40MM BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RESIDUAL MITRAL REGURGITATION. IT WAS REPORTED THAT THE 34MM MITRAL ANNULOPLASTY BAND DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15391777 ↗
• InjuryAug 29, 2022Adverse 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 34MM 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 15316468 ↗