SimuPlus™ 7700FB32 (UDI 00763000271015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000271015), received between Feb 19, 2021 and Nov 5, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 4 YEARS AND 5 MONTHS POST IMPLANT OF THIS 32MM 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: Dizziness; Dyspnea; Endocarditis; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23474028 ↗
• InjuryMay 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. IT WAS STATED THAT THE PATIENT FIRST PRESENTED WITH SUDDEN ONSET LEFT-SIDED WEAKNESS AND LEFT FACIAL DROOP. IT WAS REPORTED THAT A RIGHT SUPERIOR M2 OCCLUSION WAS DISCOVERED. IT WAS STATED THAT THE FOLLOWING DAY, THE PATIENT SYMPTOMS INCLUDED LEFT FACIAL DROOP, DYSARTHRIA, LEFT ARM WEAKNESS, LEFT LEG DRIFT, AND LEFT SIDED SENSATION CHANGE. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED RIGHT SUPERIOR M2 OCCLUSION DUE TO THE PRESENCE OF A THROMBUS IN A RIGHT M2 SEGMENT OF THE MIDDLE CERBRAL ARTERY BRANCH, PERFUSION DEFECT IN THE FRONTOTEMPORAL REGION COMPATIBLE WITH ISCHEMIA WITH PENUMBRA WITHOUT THE PRESENCE OF CORE INFARCT AND SUBTLE EARLY ISCHEMIC CHANGES IN THE RIGHT SUB INSULAR AND RIGHT FRONTAL REGIONS. A THROMBECTOMY WAS PERFORMED. IT WAS MENTIONED THAT THE PATIENT DID NOT HAVE A PRIOR HISTORY OF STROKES. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 16885821 ↗
• InjuryOct 7, 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 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. IT WAS REPORTED THAT THE ATTEMPTED REPAIR WAS UNSUCCESSFUL DUE TO THE PATIENT ANATOMY NOT BEING COMPATIBLE WITH REPAIR AND DID NOT SUCCESSFULLY RESOLVE MITRAL REGURGITATION. IT WAS STATED THAT THE ANNULOPLASTY BAND DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15565207 ↗
• InjuryJun 6, 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 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM NON-MEDTRONIC MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED TO BE DUE TO A CONCERN THAT THE REPAIR WOULD RESULT IN MITRAL STENOSIS BASED ON THE PRESENCE OF A RIGID AND THICKENED ANTERIOR LEAFLET. IT WAS MENTIONED THAT THE ANTERIOR MITRAL VALVE LEAFLET CLEFT WAS SUTURED CLOSED AND A POSTERIOR ANNULOPLASTY WAS PERFORMED USING THE 32MM MITRAL BAND. IT WAS STATED THAT DESPITE THE SEVERE REGURGITATION HAVING RESOLVED, THE ANTERIOR LEAFLET WOULD NOT OPEN AND THE BAND WAS THEN REMOVED. NO ADDITIONAL INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14607540 ↗
• InjuryJan 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13257840 ↗
• InjuryDec 3, 2021Insufficient 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 AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12923863 ↗
• InjuryDec 2, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 3 4MM MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS THAT THE SURGEON FELT THE 32 WAS NOT A GOOD SIZE FOR THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12916577 ↗
• InjuryMay 25, 2021Adverse 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 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM 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 11876728 ↗
• InjuryFeb 19, 2021Insufficient 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 28MM MITRAL ANNULOPLASTY RING OF THE SAME MODEL DUE TO RESIDUAL MITRAL REGURGITATION. THE 28MM ANNULOPLASTY BAND WAS THEN IMPLANTED, BUT THEN EXPLANTED AND REPLACED. THE 32MM ANNULOPLASTY BAND WAS THEN RE-IMPLANTED, AND A CENTRAL ALFIERI STITCH WAS PLACED TO CORRECT THE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11350126 ↗