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.
FDA Recall Z-2501-2021 · Posted None
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Recalling FirmArgon Medical Devices, Inc
Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2021-07-08
Product Quantity20 units
Reason for Recall
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Firm Action
On 07/08/2021, the firm's sales representative/clinical Specialist contacted via telephone to inform the single customer that the Recalling Firm was pausing evaluations of the affected device and was requesting return of the device. The customer was also informed that the Recalling Firm was in the process of implementing a few changes to improve upon the product. The product was place on hold at the customer's facility and the Recalling Firm's sales representative was picked up and returned to the Recalling Firm on 07/21/2021.
Root Cause
Device Design
Distribution Pattern
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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