Scorpion TPS006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333225729), received between Jul 15, 2021 and Oct 22, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗
• 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 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 ↗