Simulus™ 700FF35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169182523), received between Sep 11, 2019 and Jul 15, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 35MM MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25822916 ↗
• InjurySep 11, 2019Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 39MM ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Information

  MAUDE report 8992648 ↗