—#188893

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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K202141
Affected lot / code info: Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

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

Timeline

Recall initiated: 2021-07-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188893. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.