Simulus™ 800SC38Recalls & reported problems
Medtronic, Inc. · BAND SIM SC 800SC38 SEMI-RIGID · 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 00643169182134), received between Aug 29, 2025 and Oct 20, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 7 MONTHS POST IMPLANT OF THIS 38MM SIMULUS SR HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM DURAN ANCORE HEART BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 23336323 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 38MM ANNULOPLASTY BAND, SIGNIFICANT RESIDUAL MITRAL REGURGITATION WAS PRESENT. THEREFORE, THE 38MM ANNULOPLASTY BAND WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS MECHANICAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 22928199 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.