LSI Medical LSI-E500Recalls & reported problems
Graphic Controls Acquisition Corp · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10813150021934), received between May 14, 2026 and May 14, 2026 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Erythema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
PATIENT STATED THE ELECTRODES USED DURING THE GRADED STRESS TEST CAUSED REDNESS ON THE OUTER RING OF THE ELECTRODES NOT WHERE THE GEL IS ON THE INSIDE. PATIENT HAD REDNESS AND MULTIPLE SMALL SCABBED AREAS. PATIENT CONSULTED A PHYSICIAN AND WAS PRESCRIBED A CREAM MEDICATION. THE PATIENT'S SKIN WAS NOT PREPPED.
Patient problems: Erythema
MAUDE report 25171812 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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