Simulus™ 700FF31Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169182547), received between Aug 28, 2017 and Jan 12, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2021Adverse 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 31MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIAL TACHYCARDIA AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 11156124 ↗
• InjuryJun 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT THAT 1 YEAR POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE PATIENT REPORTED THAT THE ORIGINAL PROCEDURE "WAS NOT DONE RIGHT". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10119048 ↗
• InjuryOct 14, 2019Adverse 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 IMMEDIATELY POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9186633 ↗
• InjuryDec 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8181317 ↗
• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, SALINE CONFIRMED RESIDUAL MITRAL REGURGITATION. THE RING WAS EXPLANTED AND REPLACED WITH A 29MM NON-MEDTRONIC BIOSPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7896616 ↗
• InjuryAug 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED. NO REASON WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6823864 ↗