Simulus™ 700FF37Recalls & reported problems
Medtronic, Inc. · RING SIM 700FF37 FULLY FLEXIBLE · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169182516), received between Nov 26, 2018 and Jul 29, 2019 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Information2
- Mitral Regurgitation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT THIS 37MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH A 39MM MITRAL ANNULOPLASTY RING FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 8838750 ↗InjuryNov 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Regurgitation; No Information
MAUDE report 8104196 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.