Bard Mission Biopsy Instrument Kit cannula and needle incompatibility
Bard Mission Disposable Biopsy Instrument Kit has an incompatibility defect where the cannula is oversized relative to the needle, preventing proper insertion and tissue access. This could cause procedure delays and insufficient tissue collection.
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: This is an FDA Class II medical device recall for a structural defect where the cannula and needle are incompatible in size, preventing the instrument from functioning properly. This is a risk-of-harm product—the defect prevents proper tissue access during biopsies, which could result in inadequate samples and missed diagnoses.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Bard Mission Disposable Core Biopsy Instrument Kit. The recalled instruments include model REF 2010MSK (20G x 10 cm) and REF 2016MSK (20G x 16 cm). A total of 4,120 units were distributed nationwide throughout the United States, as well as to Belgium, Canada, and Australia.
These instruments have a manufacturing defect in which the internal diameter and length of the coaxial cannula exceed the external diameter and length of the biopsy needle. This size incompatibility prevents the biopsy needle from fitting properly into the coaxial cannula.
The defect prevents the needle from properly accessing the target tissue, which could result in procedure delays and insufficient tissue sample collection. Affected patients may require repeat procedures to obtain an adequate tissue sample.
The recalled product
- Product
- Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 4,120
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 (2)
- REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024)
- 2016MSK/00801741097096/1458844(02/28/2025)
Distribution
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