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FDAAugust 10, 2023device

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.

What to do

FDA enforcement status: Ongoing

Brands named

bard peripheral vascularbardbard peripheral

UPCs

00801741097393

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 — Recall Details · AllClear