SimuForm™ 7800RR40Recalls & reported problems
Medtronic, Inc. · RING 7800RR40 SIMUFORM SR 40MM US · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000271244), received between Feb 28, 2023 and Mar 19, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Intravalvular regurgitation1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information2
- Dyspnea1
- Foreign Body Reaction1
- Mitral Valve Insufficiency/ Regurgitation1
- Stroke/CVA1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS "FELT TO BE CARDIOEMBOLIC IN THE SETTING OF ATRIAL FIBRILLATION AND NOT RELATED TO THE VALVE". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Stroke/CVA
MAUDE report 21644458 ↗InjuryJan 27, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation
IT WAS REPORTED THAT POST IMPLANT OF THIS 40MM SINUFORM MITRAL RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MOSAIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Dyspnea; Foreign Body Reaction; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation
MAUDE report 21239996 ↗InjuryFeb 28, 2023Adverse 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 ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR THE REPLACEMENT WAS THAT THE REPAIR DID NOT WORK DUE TO THE PATIENTS ANATOMY. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 16453004 ↗
Other RING, ANNULOPLASTY devices
- CG FUTURE™ 638BL32Medtronic, Inc. · RING, ANNULOPLASTY1 death71 reports
- PROFILE 3D® 680R28Medtronic, Inc. · RING, ANNULOPLASTY1 death67 reports
- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32Medtronic, Inc. · RING, ANNULOPLASTY59 reports
- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638RL30Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.