CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report
Bard Marquee Disposable Core Biopsy Instrument Kit recalled
Bard Peripheral Vascular is recalling Bard Marquee Disposable Core Biopsy Instrument Kit, distributed nationwide in the US. The recall was initiated on 10 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0027-2024
- FDA event ID
- 92994
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Aug 2023
- FDA classified
- 4 Oct 2023
- Reported
- 11 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2023 | Recall initiated by company | |
| 4 Oct 2023 | Classified by FDA | +55 days |
| 11 Oct 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Where it was distributed
Worldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA, OR, AZ, NJ, NY, OH, NC, MD, MI, LA, IN, AK, TN and the countries of CA, AU, BE.
Nationwide AlaskaArizonaCaliforniaColoradoIndianaLouisianaMarylandMichiganNorth CarolinaNew JerseyNew YorkOhioOregonPuerto RicoTennesseeTexasWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025
Where was it sold?
Worldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA, OR, AZ, NJ, NY, OH, NC, MD, MI, LA, IN, AK, TN and the countries of CA, AU, BE.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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