Scorpion TPS005Recalls & reported problems
Argon Medical Devices, Inc. · Scorpion® - Portal Vein Access Set · Class 2
All models of Scorpion (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333225552), received between Jul 21, 2021 and Mar 1, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Jul 8, 2021Open, Classified
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Z-2501-2021 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Entrapment of Device1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
PEEK CATHETER WAS ADVANCED TOWARD THE PORTAL VEIN. THE STYLET WAS REMOVED TO ATTEMPT TO ASPIRATE PORTAL BLOOD. STYLET WAS PLACED BACK INTO THE CATHETER TO ATTEMPT ANOTHER ¿PASS¿. DISTAL 3 INCHES OF THE PEEK CATHETER WAS OBSERVED, UNDER FLUORO, TO BE DETACHED IN THE HEPATIC VEIN (SEE PICTURE). PEEK CATHETER SEGMENT WAS RETRIEVED WITH A TRIPLE LOOP SNARE FROM THE HEPATIC VEIN.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 16458137 ↗MalfunctionJul 21, 2021Entrapment of Device; Material Fragmentation
TWO FOREIGN BODIES WERE NOTICED ON POST STENT DEPLOYMENT IMAGING. A FOREIGN BODY WAS NOTICED IN THE HEART AND JAILED BETWEEN THE STENT AND BODY. THE TIP OF THE 10F SHEATH DID NOT LOOK INTACT ON IMAGING. WHEN THE SHEATH WAS REMOVED, A THE DISTAL END WAS NOT WHOLE AND A SECTION FRAGMENTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12207099 ↗
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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 · each recall links to the FDA recall notice
- 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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