SimuPlus™ 7700FR32Recalls & reported problems
Medtronic, Inc. · Ring 7700FR32 SimuPlus Flex 32mm GLB · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00763000271404), received between Feb 18, 2025 and May 13, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Intravalvular regurgitation1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information2
- Mitral Valve Insufficiency/ Regurgitation1
- Tachycardia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT POST IMPLANT OF THIS 32MM SIMUPLUS MITRAL RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM DURA ANCORE MITRAL BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 22010084 ↗InjuryFeb 18, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation
ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS MODERATE MITRAL REGURGITATION, AS THE ANTERIOR LEAFLET WAS MYXOMATOUS AND REDUNDANT, AND THE POSTERIOR LEAFLET HAS RETRACTED SEGMENTS. THE ANNULOPLASTY RING WAS FULLY SUTURED AND TESTED PRIOR TO EXPLANT FOR ANOTHER MANUFACTURERS BIOPROSTHETIC VALVE. IT WAS ALSO REPORTED THAT AFTER IMPLANT, THERE WAS PULSELESS VENTRICULAR TACHYCARDIA, REQUIRING COMPRESSIONS AND DEFIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Tachycardia
MAUDE report 21399219 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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