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.
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- July 8, 2021
- Recall Number
- Z-2501-2021
- Quantity
- 20 units
- Firm Location
- Athens, TX
Reason for Recall
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Distribution
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Lot / Code Info
Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Root Cause
Device Design
Action Taken
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.