SimuPlus™ 7700FB30 (UDI 00763000271305)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000271305), received between Mar 7, 2023 and May 7, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH 32MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION AND WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS ALSO NOTED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25109241 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM 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 24468428 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23451465 ↗
• InjuryMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A HEART BAND WAS IMPLANTED AND THEN EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22086645 ↗
• InjuryFeb 12, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT AN ECHOCARDIOGRAM PERFORMED NOTED THAT THE LATERAL ASPECT OF THE POSTERIOR (P3) SCALLOP WAS PARTIALLY FLAIL WITH SEVERE MITRAL REGURGITATION. IT WAS REPORTED THAT THE 30MM MITRAL ANNULOPLASTY BAND WAS WELL-SEATED IN THE MITRAL POSITION. IT WAS STATED THAT THE PATIENT WAS EXPERIENCING INCREASED SHORTNESS OF BREATH WITH EXERTION AND OCCASIONALLY HAS PRESYNCOPE. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation; Syncope/Fainting

  MAUDE report 21362514 ↗
• InjuryDec 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM 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 21018333 ↗
• InjurySep 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM 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 20302695 ↗
• InjuryAug 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM 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 20029254 ↗
• InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 25MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19447572 ↗
• 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 18847450 ↗
• InjurySep 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REPLACEMENT PRODUCT AS A 31MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS ALSO REPORTED AS A "FAILED REPAIR" AND DUE TO "DIFFICULT PATIENT ANATOMY". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17711368 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF A 30MM MITRAL ANNULOPLASTY BAND AND A 28MM TRICUSPID ANNULOPLASTY BAND, D URING AN ELECTROCARDIOGRAM (ECG), ATRIAL FLUTTER WITH A 4:1 ATRIOVENTRICULAR (AV) CONDUCTION RATIO WAS NOTED. THE PATIENT WAS RESTARTED ON ANTIARRHYTHMIC MEDICATION. 11 DAYS LATER, THE PATIENT UNDERWENT CARDIOVERSION AND CONVERTED BACK TO SINUS RHYTHM WITH 1ST DEG REE AV BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 17277966 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 16794685 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF WORSENING VISUAL FIELD DEFICITS, CONFABULATION AND LEFT SIDED WEAKNESS. A MAGNETIC RESONANCE IMAGING (MRI) DISCOVERED NUMEROUS ACUTE, SUBACUTE AND AREAS OF SUSCEPTIBILITY ENHANCEMENT, INCLUDING REMOTE LEFT FRONTAL INFARCTION. ONE DAY LATER, A COMPUTERIZED TOMOGRAPHY (CT) SCAN DISCOVERED EVOLVING TERRITORIAL HYPOINTENSITY IN THE BILATERAL PARIETO-OCCIPITAL REGIONS, LIKELY REPRESENTING EVOLVING INFARCTIONS. THAT SAME DAY, AN ECHOCARDIOGRAM (ECHO) DISCOVERED MINIMALLY THICKENED MITRAL VALVE LEAFLETS WITH A MEAN GRADIENT OF 6MMHG. ANTICOAGULATION MEDICATIONS WERE CONTINUED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Blurred Vision; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 16677271 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THE PATIENT WAS HOSPITALIZED AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN DISCOVERED INTERNAL EVOLUTION OF THE KNOWN INFARCTION IN THE LEFT OCCIPITAL REGION, AN ELECTROCARDIOGRAM (ECG) DISCOVERED NORMAL SINUS RHYTHM AND A DIAGNOSTIC MAGNETIC RESONANCE IMAGINING (MRI) DISCOVERED LEFT PARASAGITTAL OCCIPITAL LOBE ACUTE ISCHEMIC INFARCTION ALONG WITH SMALL SUBCORTICAL INFARCTIONS IN THE LEFT FRONTAL AND RIGHT PARIETAL LOBES. ONE DAY LATER, AN ECHOCARDIOGRAM (ECHO) DISCOVERED MINIMAL MITRAL REGURGITATION WITH A MEAN GRADIENT OF 14MMHG. IT WAS ALSO REPORTED THAT THE STROKES WERE LIKELY EMBOLIC IN THE SETTING OF KNOWN ANTIPHOSPHOLIPID SYNDROME (APS) AND FACTOR V LEIDEN AND HOLDING OF ANTICOAGULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Stroke/CVA

  MAUDE report 16676424 ↗
• InjuryMar 14, 2023Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR REPLACEMENT WAS SEVERE MITRAL REGURGITATION DUE TO PARTIAL BAND DEHISCENCE. IT WAS ALSO MENTIONED THAT HEMOLYSIS WAS NOTED PRIOR TO REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemolysis; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16539116 ↗
• InjuryMar 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MDT PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16499453 ↗