SimuForm™ 7800RR36 (UDI 00763000271220)Recalls & reported problems
Medtronic, Inc. · RING 7800RR36 SIMUFORM SR 36MM US · Class 2 · Implant
All models of SimuForm (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00763000271220), received between Jan 14, 2022 and Jan 21, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Intravalvular regurgitation1
Patient problems
- Insufficient Information2
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2026Intravalvular regurgitation
ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, AN UNKNOWN DURATION LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE -IN-RING. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 24129981 ↗InjuryMar 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, 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 18941170 ↗InjuryJan 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33 MM NON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 13260453 ↗
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- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638BL28Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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