ASTODIA DIA100Recalls & reported problems
Stihler Electronic GmbH · DIA100 · Class 1
Data updated Oct 16, 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 04260114140214), received between Jan 29, 2026 and Jan 29, 2026 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blister1
- Burn(s)1
- Erythema1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
ASTODIA TRANSILLUMINATOR USED FOR PERIPHERAL INTRAVENOUS PLACEMENT - NURSE NOTED THAT RED AREA WAS FORMING WHERE THE LIGHT TOUCHED INFANT'S ARM. AREA WAS NOT OPEN AT THAT TIME BUT DID EVENTUALLY BLISTER AND REQUIRE BACITRACIN.
Patient problems: Blister; Erythema; Partial thickness (Second Degree) Burn
MAUDE report 24208894 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
ASTODIA TRANSILLUMINATOR USED FOR PERIPHERAL ARTERIAL LINE PLACEMENT AND RESULTED IN 2 BURNS ON INFANT'S ARM.
Patient problems: Burn(s)
MAUDE report 24208789 ↗
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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