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Recall Observatory FDA recall evidence

Device product

Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

Z-2501-2021

July 08, 2021

Class II

Product summary

Firm
Argon Medical Devices, Inc
Event
Event 88520
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-2501-2021

Official wording

Reason: As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

Code information: Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609

Distribution pattern: U.S. Nationwide distribution in the state of WA. O.U.S.: N/A

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    design changes, sheaths have exhibited cracking/breaking

Field note

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