SimuPlus™ 7700FB42 (UDI 00763000271060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000271060), received between Jun 29, 2022 and Oct 15, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 YEARS AND 5 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND AND A 42MM MITRAL ANNULOPLASTY BAND, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PALPITATIONS AND CHEST PAIN AND WAS FOUND TO BE IN ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RATE (RVR). IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ANTIARRHYTHMIC MEDICATIONS AND 1 DAY LATER, CONVERTED TO NORMAL SINUS RHYTHM. IT WAS STATED THAT AN ANTIARRHYTHMIC MEDICATION WAS DISCONTINUED DUE TO RECURRENCE OF ATRIAL FIBRILLATION WITH ELEVATED LIVER FUNCTION TESTS. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Chest Pain

  MAUDE report 23301866 ↗
• InjuryApr 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY RING, ATRIAL FIBRILLATION WAS OBSERVED ON AN ELECTROCARDIOGRAM (ECG). IT WAS STATED THAT THE PATIENT WAS FEELING WELL BUT HAD PALPITATIONS WITH ATRIAL FIBRILLATION OVERNIGHT, THEREFORE WAS PLACED ON INTRAVENOUS (IV) THERAPY WITH AN ANTIARRHYTHMIC MEDICATION. IT WAS REPORTED THAT THE PATIENTS RATE IMPROVED AND THEIR MAGNESIUM WAS REPLACED. IT WAS NOTED THAT THE PATIENT WAS RESUMED ON BETA BLOCKERS AND STARTED ON ANTICOAGULANT MEDICATION. THE SITE ASSESSED THAT THE EVENT IS RELATED TO THE DEVICE AND TO THE IMPLANT PROCEDURE. IT WAS REPORTED THAT A FOLLOW-UP ELECTROCARDIOGRAM (ECG) PERFORMED ONE MONTH LATER SHOWED AN ATRIAL FLUTTER. IT WAS STATED THAT THE PATIENT HAS A RATE OF 79 BEATS PER MINUTE (BPM) DUE TO ONGOING ATRIAL FIBRILLATION (AFIB) ATRIAL FLUTTER. 4 DAYS FOLLOWING THE ECG, CARDIOVERSION WAS PERFORMED. AN ECG PERFORMED 3 DAYS FOLLOWING CARDIOVERSION SHOWED SINUS RHYTHM WITH PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND PREMATURE VENTRICULAR CONTRACTIONS (PAC). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19050027 ↗
• InjuryAug 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 38MM BAND OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17601989 ↗
• InjurySep 2, 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 42MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A N ON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE PATIENT'S ANATOMY NOT BEING COMPATIBLE WITH REPAIR. IT WAS REPORTED THAT THE PATIENT'S ANULUS WAS VERY COMPLICATED WHICH MADE THE IMPLANT DIFFICULT AND THERE WAS NO MALFUNCTION OF THE ANNULOPLASTY BAND ITSELF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15348751 ↗
• InjuryJun 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT DUE TO UNSUCCESSFUL REPAIR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14853029 ↗