The Recall Desk
SevereFDA (Devices)·Z-1073-2021·Announced 2021-02-17

Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

Argon Medical Devices is recalling 863 TLAB Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the defect could result in permanent damage to a body structure or permanent impairment of a body function, which aligns with the rubric criterion for 'significant injury' reports or risks.

Plain-English summary

Argon Medical Devices, Inc. is recalling 863 units of the TLAB Transjugular Liver Biopsy System (REF: TL-19). The affected products include the 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath with Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, and 5F Curved Catheter. The recall covers specific lot numbers: 1428364, 1451428, and 1486448.

The recall is due to a manufacturing error that creates a potential for the sheath within the biopsy kit to separate during use if the tip is flexed or experiences bending stresses. This defect could result in the need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.

The affected units were distributed to various U.S. states and territories, as well as several international locations including Switzerland, Saudi Arabia, and Canada. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it state if any injuries have been reported.

The recalled product

Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Biopsy System
Hazard
Affected units
863

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Number: 1428364
  • 1451428
  • 1486448

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 6 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

See all →

Same hazard · structural failure

See all →