Agency classClass IIOur severity:High FDA (Devices)·Z-1289-2021·Announced 2021-03-31

Bard Marquee Biopsy Instruments Recalled for Detaching Switch

Bard Peripheral Vascular Inc is recalling Marquee Disposable Core Biopsy Instruments because the penetration depth switch may detach during use.

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 3/5 (High).

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: The recall is classified as FDA Class II, and the hazard involves a component detaching during a medical procedure, which presents a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Bard Peripheral Vascular Inc is recalling the BARD MARQUEE Disposable Core Biopsy Instruments. The recall involves 131,876 kits, including 102,210 kits distributed in the United States and 29,666 kits distributed outside the United States.

The recall was initiated because the Penetration Depth Switch, which is used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, may detach from the device during use. The affected products are distributed across all 50 U.S. states, the District of Columbia, and Puerto Rico, as well as in Australia, Belgium, Canada, Europe, India, and Singapore.

Healthcare providers and consumers should stop using the affected devices and contact Bard Peripheral Vascular Inc for further instructions on how to return or replace the products.

The recalled product

Product: BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Biopsy Instruments
Hazard: component-detachment

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 (20)

12g x 10cm
MQ1213 BARD MARQUEE Disposable Core Biopsy Instrument
12g x 13cm
MQ1410 BARD MARQUEE Disposable Core Biopsy Instrument
14g x 10cm
MQ1413 BARD MARQUEE Disposable Core Biopsy Instrument
14g x 13cm
MQ1416 BARD MARQUEE Disposable Core Biopsy Instrument
14g x 16cm
MQ1610 BARD MARQUEE Disposable Core Biopsy Instrument
16g x 10cm
MQ1616 BARD MARQUEE Disposable Core Biopsy Instrument
16g x 16cm
MQ1620 BARD MARQUEE Disposable Core Biopsy Instrument
16g x 20cm
MQ1810 BARD MARQUEE Disposable Core Biopsy Instrument
18g x 10cm
MQ1816 BARD MARQUEE Disposable Core Biopsy Instrument
18g x 16cm
MQ1820 BARD MARQUEE Disposable Core Biopsy Instrument

Distribution

Distributed in 52 states:

Same manufacturer · Bard Peripheral Vascular Inc

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Same hazard · component detachment