Skip to content
Recall Observatory FDA recall evidence

Derived label

Device software or design

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.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
design changes, sheaths have exhibited cracking/breaking
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Argon Medical Devices, Inc

Field note

Send feedback

We'll only use this to respond to your feedback.