SimuPlus™ 7700FB40 (UDI 00763000271053)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000271053), received between Feb 16, 2023 and Dec 1, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 40MM 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 18248745 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 22 DAYS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT ARRIVED TO THE EMERGENCY DEPARTMENT AND RECEIVED A DIAGNOSTIC ELECTROCARDIOGRAM (ECG) WHICH DISCOVERED ATRIAL FIBRILLATION (AFIB) WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT WAS THEN HOSPITALIZED. ONE DAY LATER, A SECOND ECG DISCOVERED AFIB WITH RVR. ONE DAY LATER, THE PATIENT UNDERWENT CARDIOVERSION. LASTLY, ONE DAY LATER, THE PATIENT DISCHARGED FROM THE HOSPITAL AND RECOVERED/RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 16386777 ↗