SimuPlus™ 7700FB36 (UDI 00763000271336)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00763000271336), received between Jun 14, 2022 and May 12, 2026 — classified as 1 death, 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RESIDUAL REGURGITATION. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT DID MALFUNCTION AND THE DEVICE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS ALSO NOTED THAT THE PATIENT DID HAVE PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25147488 ↗
• InjuryApr 21, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD-MODERATE MITRAL REGURGITATION (MR). IT WAS ALSO NOTED THAT THE PATIENT WAS FOUND TO HAVE A LARGE RIGHT PLEURAL EFFUSION WHICH WAS DRAINED DURING SURGERY. THE DEVICE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Pleural Effusion

  MAUDE report 24940064 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 4 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM MITRAL A NNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24187777 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 36MM 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 24078772 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, 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 23987969 ↗
• InjuryOct 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 WEEK POST IMPLANT OF THIS 36MM SIMUPLUS HEART BAND, THE PATIENT PRESENTED TO HOSPITAL ON FOR ACUTE ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. HE CONVERTED TO SINUS RHYTHM AFTER AMIODARONE AND UP-TITRATION OF BETA BLOCKADE THERAPY. HE WAS DISCHARGED HOME THE NEXT DAY. IT WAS NOTED SUBJECT HAD ANOTHER EPISODE OF ATRIAL FIBRILLATION THAT SELF-RESOLVED WITH MEDICAL THERAPY. SUBJECT DOES NOT HAVE A PAST MEDICAL HISTORY OF ATRIAL FIBRILLATION; THEREFORE, IT COULD BE ATTRIBUTED TO THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 23411448 ↗
• MalfunctionOct 17, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 1 MONTH POST IMPLANT OF THIS 36 MM MITRAL ANNULOPLASTY BAND, AN ECHOCARDIOGRAM PERFORMED DEMONSTRATED MINIMAL MI TRAL REGURGITATION. SUBSEQUENTLY, IT WAS REPORTED THAT A TRANSTHORACIC ECHOCARDIOGRAPHY (TEE) PERFORMED ON (B)(6) 2025, DEMONSTRATED MODERATE MITRAL REGURGITATION. IT WAS STATED THAT A VALVE INTERVENTION WAS NOT NECESSARY AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23323033 ↗
• DeathOct 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE CAUSE OF DEATH AS INTRACEREBRAL HEMORRHAGE. IT WAS FURTHER REPORTED THAT THE INTRACEREBRAL HEMORRHAGE OCCURRED DURING A HYPERTENSIVE EMERGENCY, WHILE ALSO BEING PRESCRIBED ANTICOAGULATION MEDICATION FOR ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Insufficient Information; Intracranial Hemorrhage

  MAUDE report 23322579 ↗
• InjuryAug 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, THE PATIENT DEVELOPED NONSUSTAINED VENTRICULAR TACHYCARDIA (NSVT). IT WAS REPORTED THAT AN ANTIARRHYTHMIC MEDICATION WAS GIVEN AND THE EVENT RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 22715884 ↗
• InjuryJul 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND AND 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND ATRIAL FLUTTER. CARDIOVERSION WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter

  MAUDE report 22591377 ↗
• MalfunctionJul 23, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 8 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED MODERATE MITRAL REGURGITATION WITH A CENTRAL JET. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22575732 ↗
• InjuryJul 22, 2025Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT EXPLANTATION OF AN OLD HEART BAND DEVICE AND IMPLANTATION OF A NEW HEART BAND DEVICE IN THE MITRAL POSITION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22566595 ↗
• InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 36 MM 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 21900215 ↗
• InjuryFeb 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 36MM SIMUPLUS MITRAL BAND, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21469681 ↗
• InjuryNov 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM 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 20788861 ↗
• InjuryNov 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM 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 20675130 ↗
• InjuryMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 72 HOURS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM (ECG) INDICATED ATRIAL FIBRILLATION (AFIB) WITH RAPID VENTRICULAR RESPONSE (RVR) AND INCOMPLETE RIGHT BUNDLE BRANCH BLOCK (RBBB). THE PATIENT WAS GIVEN MEDICATION AND THE EVENT RESOLVED. SUBSEQUENTLY 4 DAYS LATER, A SECOND ECG INDICATED NORMAL SINUS RHYTHM AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18893357 ↗
• InjuryFeb 20, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT IS BEING EVALUATED FOR A REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE MITRAL REGURGITATION (MR) SECONDARY TO MITRAL RING SUTURE RUPTURE. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18740766 ↗
• InjuryFeb 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 36MM 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 18699666 ↗
• InjuryNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM 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 18239666 ↗
• InjuryAug 31, 2023Adverse 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 36MM MITRAL ANNULOPLASTY BAND, ATRIAL FLUTTER WITH VARIABLE ATRIO-VENTRICULAR BLOCK WAS OBSERVED ON A ELECTROCARDIOGRAM. NO INTRACARDIAC THROMBUS WAS OBSERVED. CARDIOVERSION WAS PERFORMED 1 DAY FOLLOWING THIS OBSERVATION. 3 DAYS FOLLOWING TREATMENT, AN ELECTROCARDIOGRAM REVEALED ONGOING ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSES. IT WAS STATED THAT THE ATRIAL FIBRILLATION AND ATRIAL FLUTTER WAS RELATED TO THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17664142 ↗
• InjuryAug 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 21 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM 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 17455586 ↗
• InjuryJul 21, 2023Adverse 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 7 DAYS POST IMPLANT OF THIS 36MM 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 17370972 ↗
• InjuryJul 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 21 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND , THE PATIENT IS BEING EVALUATED FOR A POSSIBLE ISCHEMIC STOKE. THE REASON FOR EVALUATION WAS REPORTED AS THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR RIGHT SIDED FACIAL DROOP AND DIFFICULTY SPEAKING. SLURRED SPEECH AND RIGHT-SIDED FACIAL PARALYSIS WERE NOTED NUMEROLOGY EXAM INDICATED NO FOCAL NEUROLOGIC DEFICIT AND SCORED A 1 ON THE NATIONAL INSTITUTES OF HEALTH (NIH) SCALE. COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE HEAD SHOWED NO BLEEDING.  ELECTROCARDIOGRAM (ECG) SHOWED NORMAL SINUS RHYTHM. ECHOCARDIOGRAM (ECHO)  SHOWED MEAN GRADIENT OF 2 MMHG AND MINIMAL REGURGITATION. MAGNETIC RESONANCE IMAGING (MRI) SHOWED ACUTE/EARLY SUBACUTE ISCHEMIC INSULT INVOLVING THE LEFT PRECENTRAL GYRUS AND TIGHT PERIPHERAL CEREBELLAR PARENCHYMA PARTS OF THE BRAIN. PATIENT WAS ADMITTED FOR FURTHER MANAGEMENT OF TRANSIENT ISCHEMIC ATTACK (TIA), ANTICOAGULANTS WERE STARTED AND PATIENT WAS DISCHARGED TWO DAYS LATER. NO SURGICAL INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Transient Ischemic Attack

  MAUDE report 17247061 ↗
• InjuryNov 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM TRICUSPID ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15880032 ↗