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.
Recall
- Recall Number
- Z-2501-2021
- Event Number
- 88520
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- DYB
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- July 8, 2021
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
Description
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.
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
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.
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
20 units