SimuPlus™ 7700FB38 (UDI 00763000271343)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000271343), received between Apr 13, 2022 and May 21, 2026 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 38MM 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 25239624 ↗
• InjuryApr 28, 2026Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF RESIDUAL REGURGITATION WAS MODERATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25012375 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 10  MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24520301 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 38MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. IT WAS ALSO REPORTED THE INITIAL 38MM BAND WAS "WASTED". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24207902 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1 YEARS AND 5 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A 32MM MITRAL HEART 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 23642410 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING A PROCEDURE, A HEART BAND WAS IMPLANTED AND EXPLANTED, AND A TISSUE VALVE WAS IMPLANTED. THE REASON FOR REPLACEMENT WAS REPORTED AS THE PATIENT HAD RESTRICTED LEAFLETS, AS THERE WAS NOT ENOUGH COAPTATION FOR A COMPLETE SEAL. RESIDUAL REGURGITATION COULD BE SEEN AFTER IMPLANT, ALONG WITH SYSTOLIC ANTERIOR MOTION. IT WAS FURTHER REPORTED THAT THE ANNULOPLASTY BAND WAS SUTURED AND TESTED PRIOR TO REMOVAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21742947 ↗
• InjuryFeb 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM 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 21447977 ↗
• InjuryJul 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM 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 19659001 ↗
• InjuryMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAYS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND AND A 28MM TRICUSPID ANNULOPLASTY BAND, ELECTROCARDIOGRAM (EKG) PERFORMED NOTED THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK WITH JUNCTION RHYTHM. IT WAS REPORTED THAT 6 DAYS LATER, EKG PERFORMED NOTED BRADYCARDIA WITH COMPLETE HEART BLOCK. MEDICATION WAS ADMINISTERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Heart Block

  MAUDE report 18893969 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS "WASTED". IT WAS ALSO REPORTED THAT AFTER THE 3RD "PUMP RUN", THE SURGEON DECIDED TO REMOVE THE BAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18317543 ↗
• InjuryMar 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT A DIAGNOSTIC ELE CTROCARDIOGRAM (ECG) DISCOVERED ATRIAL FIBRILLATION. IT WAS ALSO REPORTED THAT RAPID VENTRICULAR RATE WAS DISCOVERED. MEDICATION WAS GIVEN VIA 2 INTRAVENOUS (IV) BOLUSES AND ORALLY. THE PATIENT CONVERTED TO SINUS RHYTHM ONE DAY LATER. THE PATIENT HAS RECOVERED/RES OLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 16574191 ↗
• InjuryJun 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 2 7MM BIOPROSTHESIC 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 14717826 ↗
• InjuryApr 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM 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 14106273 ↗