ScorpionRecalls & reported problems across all models

We found 2 models of Scorpion by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jul 15, 2021 and Oct 22, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Scorpion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 Scorpion problems

Scorpion models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Scorpion TPS005

  Introducer, Catheter
  1 recall2 reports
• Scorpion TPS006

  Introducer, Catheter
  5 reports

Recent Scorpion adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Break; Break

  DURING THE PROCEDURE, THE SCORPION X SET WAS USED AS TRANSJUGULAR ACCESS TO THE PORTAL VEIN. WHEN MANIPULATING THE PEEK CATHETER TOGETHER WITH THE PUNCTURE NEEDLE (17 G), THE PEEK COMPONENT FRACTURED (BROKE), LEAVING A SEGMENT OF IT RETAINED INSIDE THE PATIENT (APPROXIMATELY 3.5 CM). THE BREAKAGE OCCURRED DURING THE FIRST PUNCTURE ATTEMPT; THE DISTAL TIP OF THE PEEK CATHETER BROKE IMMEDIATELY. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO RECOVER THE COMPONENT ENDOVASCULARLY, BUT THIS WAS UNSUCCESSFUL. THE MATERIAL REMAINS IN THE PATIENT. CURRENTLY, THE SEGMENT THAT REMAINED INSIDE THE PATIENT MIGRATED TO A HEPATOPULMONARY SHUNT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23359497 ↗
• 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 ↗
• MalfunctionSep 6, 2022Material Twisted/Bent

  DURING TIPS PROCEDURE MULTIPLE PASSES WERE MADE TOWARDS THE PORTAL SYSTEM AND THE NEEDLE KEPT DEFLECTING FURTHER THEN ANTICIPATED. DURING INSPECTION OF THE DEVICE IT SEEMS THE NEEDLE BEND ADDITIONALLY DURING THE PASSES MADE. VISUALLY THE NEEDLE LOOKED BENT AT THE POINT BETWEEN NITINOL AND STAINLESS STEEL. THE SYSTEM WAS USED AS DESIGNED PER IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15365184 ↗
• MalfunctionAug 22, 2022Break

  BROKE IN THE SHEATH WHILE IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15266753 ↗
• MalfunctionJun 20, 2022Detachment of Device or Device Component

  WHILE MAKING PASSES WITH THE SCORPION X NEEDLE¿THE TECH NOTICED THAT THE PEEK CATHETER WAS SHORTER THAN NORMAL AND NOT ABLE TO COVER THE NEEDLE TIP. THAT¿S WHEN WE ALL REALIZED THAT THE PEEK CATHETER MUST HAVE BEEN SHEARED OFF DURING PASS ATTEMPTS IN THE LIVER. DR HALL WAS ABLE TO VERIFY THAT THE PORTION OF THE PEEK CATHETER WAS STILL IN THE PATIENTS LIVER PARENCHYMA VIA FLUOROSCOPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14742823 ↗
• 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 ↗
• MalfunctionJul 15, 2021Break; Failure to Advance

  INTRODUCER SHEATH WOULD NOT TRACK THROUGH LIVER PARACHEYMA. TIP OF SHEATH BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177521 ↗

Other Argon Medical Devices, Inc. products

• First PICC S/L Peripherally Inserted Central Catheter5 models · 174 reports
• BioPince Ultra Full Core Biopsy Instrument10 models · 85 reports · 1 recall
• BioPince Full Core Biopsy Instrument5 models · 60 reports · 1 recall
• L-Cath PICC S/L2 models · 30 reports · 1 recall
• Tru-Core II Biopsy Instrument8 models · 13 reports · 1 recall
• Arterial Line Kit2 models · 2 reports · 1 recall
• Tru-Core II URO Biopsy Instrument2 models · 2 reports · 1 recall
• Transvenous Pacing Electrode Tray2 models · 0 reports · 1 recall