SimuPlus™ 7700FB26 (UDI 00763000271282)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000271282), received between Nov 2, 2022 and Jul 17, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTHS POST IMPLANT OF THIS 26MM TRCUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM TRCUSPID 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 25855206 ↗
• InjuryDec 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 DAYS POST IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AVB) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23714343 ↗
• InjurySep 30, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR THE REPLACEMENT WAS SEVERE REGURGITATION. IT WAS NOTED THAT THE PATIENT HAD A SMALL MITRAL VALVE ANNULAR SIZE AND THE VALVE WAS FLAIL. IT WAS STATED THAT THE DEVICE DID NOT MALFUNCTION. THE ANNULOPLASTY BAND WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A 27MM MITRAL VALVE OF A DIFFERENT MANUFACTURER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20339595 ↗
• InjuryMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENTS "INT RA-OPERATIVE COURSE WAS COMPLICATED BY JUNCTIONAL RHYTHM". TWO DAYS POST PROCEDURE, THE PATIENT DEVELOPED ATRIAL FIBRILLATION, ON DAY 3 POST PROCEDURE, THE ATRIAL FIBRILLATION CONVERTED BACK TO JUNCTIONAL RHYTHM, AND ON DAY 4 POST PROCEDURE, JUNCTIONAL RHYTHM "RE- CONVERTED TO ATRIAL FIBRILLATION." ON DAY 5 POST PROCEDURE, THE PATIENT "DEVELOPED BRADYCARDIA REQUIRING PACING", AND ON DAY 6 POST PROCEDURE, THE PATIENT WAS "IN SINUS BRADYCARDIA TO SINUS RHYTHM WITH A RATE OF 50'S-60'S". IT WAS REPORTED THAT 16 DAYS POST PROCEDURE, THE PATIENT HAD A DIAGNOSTIC ELECTROCARDIOGRAM (ECG) WHICH INDICATED ATRIAL FLUTTER WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT WAS GIVEN MEDICATION AND CONVERTED BACK TO SINUS RHYTHM. IT WAS RECOMMENDED TO THE PATIENT TO UNDERGO A CARDIOVERSION. PATIENT UNDERWENT CARDIOVERSION 47 DAYS LATER. IT WAS STATED THAT THE PHYSICIAN BELIEVES THE BAND OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE CONDUCTION DISTURBANCE AS THE PATIENT DID NOT HAVE ANY HISTORY OF ARRHYTHMIAS PRIOR TO THE BAND IMPLANT PROCEDURE. SUBSEQUENTLY, 4

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

  MAUDE report 18896253 ↗
• InjuryAug 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM 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 17629894 ↗
• InjuryJun 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM 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 17158191 ↗
• InjuryMay 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY BAND 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 16938589 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 15714241 ↗