Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 247 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect could result in the need for surgical intervention to prevent or reverse permanent damage to a body structure or permanent impairment of a body function, which aligns with the rubric criterion for 'significant injury' or 'structural vehicle defect' (analogous to structural medical device defect) under the Severe (4) category.
Plain-English summary
Argon Medical Devices, Inc. is recalling 247 units of the TLAB Transjugular Liver Biopsy System (REF: TL-19S). The recall involves specific lot numbers: 1439835, 1451429, and 1486445. The affected products were distributed across numerous US states and territories, as well as internationally to countries including Switzerland, Saudi Arabia, and Canada.
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 prevent or reverse permanent damage to a body structure or permanent impairment of a body function.
The source text does not specify specific actions for consumers or healthcare providers, such as returning the product or contacting the manufacturer. Users of these devices should consult their healthcare provider or the manufacturer for guidance on the recall.
The recalled product
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Biopsy System
- Affected units
- 247
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: 1439835
- 1451429
- 1486445
Distribution
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.
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