Traveler TPS002Recalls & reported problems
Argon Medical Devices, Inc. · Traveler™21 (21ga Needle Portal Vein Access Set) · Class 2
Data updated Oct 18, 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 00886333224630), received between Mar 25, 2021 and Mar 25, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Failure to Advance1
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.
MalfunctionMar 25, 2021Failure to Advance
THE 10F SHEATH COULD NOT BE ADVANCED INTO THE DILATED LIVER PARENCHYMA OVER A 0.035¿ BOSTON SCIENTIFIC SUPER STIFF AMPLATZ WIRE. THE DR. TRIED TO REINSERT THE 10F INTRODUCER (BLUE ARGON), BUT IT WOULD NOT ADVANCE INTO THE SHEATH. A COOK 10F INTRODUCER (GREY, STI LL IN SHEATH FOR RETURN & IN PICS) WAS THEN INSERTED BUT WOULD NOT BE ADVANCED BEYOND A CERTAIN POINT INTO THE SHEATH. THE ENTIRE SHEATH HAD TO BE EXCHANGED AND REMOVED FOR ANOTHER NEW SHEATH. THE PATIENT EXPERIENCED AN INTRAPERITONEAL HEMORRHAGE AFTER THE EXCHANGE OF THE SHEATH IN THE DILATED PARENCHYMA WHERE THE SHEATH WAS SUPPOSED TO BE ADVANCED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 11572437 ↗
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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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