ASTOTUBE® IFT40410Recalls & reported problems
Stihler Electronic GmbH · PVC infusion extension · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260114140610), received between Jul 8, 2024 and Jul 8, 2024 — classified as 1 malfunction.
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
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2024
DURING A ROUTINE PLASMA EXCHANGE THE CONNECTION (LUER TYPE) BETWEEN THE APHERESIS SET AND THE WARMER TUBING SET VIBRATED LOOSE ALLOWING < 100 ML OF BLOOD LOSS. DURING SETUP THIS OPERATOR ENSURED THE CONNECTION WAS VERY TIGHT (AS THIS INCIDENT HAS HAPPENED BEFORE) AND WHEN LEAK WAS DISCOVERED IT WAS FOUND TO BE "FINGER TIGHT." THERE WAS NO COMPLETE SEPARATION OF THE LINES, BUT ENOUGH THAT BLOOD WAS ALLOWED TO LEAK OUT VIA THE THREADED CONNECTION. THE CONNECTION WAS RE-TIGHTENED AND MONITORED THE REMAINDER OF THE PROCEDURE. PATIENT WAS STABLE THROUGHOUT, NO CHANGES IN HGB/HCT NOTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19688802 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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