Bard Marquee Core Biopsy Kit recalled for needle-cannula diameter mismatch
Bard Peripheral Vascular is recalling 1,545 Bard Marquee biopsy kits because of a diameter mismatch between the biopsy needle and coaxial cannula. This defect may prevent proper tissue access during procedures and lead to complications including bleeding and pneumotharax.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall where a manufacturing defect (diameter mismatch) prevents proper function during a medical procedure. The source identifies serious potential complications including pneumotharax and bleeding, fitting the rubric criterion of a 'risk-of-harm product where injury has not yet been reported.'
Plain-English summary
Bard Peripheral Vascular Inc. is recalling the Bard Marquee Disposable Core Biopsy Instrument Kit (REF: MQK2016) due to a manufacturing defect affecting 1,545 units distributed worldwide. The kit contains a diameter mismatch between the coaxial cannula (outer needle) and the biopsy needle (cutting cannula). The inner diameter of the coaxial cannula is too small, preventing the biopsy needle from fitting properly inside it and accessing target tissue as intended.
This defect may lead to repeated procedures and procedural complications including pain, discomfort, pneumothorax (lung collapse), and bleeding. The affected lot number is 0001480774, and the product is set to expire July 28, 2025.
Patients and healthcare providers with this product should stop using it immediately and contact Bard Peripheral Vascular Inc. for instructions on return, replacement, or disposal. Any adverse events or injuries should be reported to the FDA.
The recalled product
- Product
- Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- mechanical-defect
- pneumotharax
- bleeding
- procedure-complication
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)
- UDI-DI: 00801741097393
- Lot: 0001480774
- Exp: 07/28/2025
Distribution
Distributed nationwide across the United States.
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