The Recall Desk
SevereFDA (Devices)·Z-1077-2021·Announced 2021-02-17

Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

Argon Medical Devices is recalling 583 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 recall is classified as FDA Class II and the source text explicitly states the defect could result in permanent damage to a body structure or permanent impairment of a body function, meeting the criteria for a Severe rating.

Plain-English summary

Argon Medical Devices, Inc. is recalling 583 units of the TLAB Transjugular Liver Biopsy System (REF: TL-18N). The affected products include a 1/18 GA Flexcore Biopsy Needle, a 1/7F Introducer Sheath with Curved Metal Stiffener, and 4 Tissue Removal Swabs. The recall covers specific lot numbers: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, and 1495182.

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 products were distributed in the United States (including Puerto Rico) and internationally to countries including Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, Vietnam, Slovakia, and Spain. Healthcare providers and facilities should stop using the affected units and contact Argon Medical Devices for further instructions.

The recalled product

Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Biopsy System
Hazard
Affected units
583

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 (7)

  • Lot Number: 1394204
  • 1424962
  • 1464709
  • 1473181
  • 1477229
  • 1481735
  • 1495182

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 →

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