Bard Max-Core Biopsy Instrument Recalled for Firing Failures
Bard Peripheral Vascular Inc is recalling 727,034 units of the Bard Max-Core Disposable Core Biopsy Instrument due to complaints of failure to fire and failure to obtain samples.
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 device is a risk-of-harm product where the failure to obtain samples could impact patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 727,034 units of the Bard Max-Core Disposable Core Biopsy Instrument. The device is intended for obtaining biopsies from soft tissues such as the liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors, but is not intended for use in bone.
The recall was initiated after the firm's review of May 2019 complaint data revealed a significant increase in complaints regarding the device's performance. Specifically, the complaints cited issues with failure to fire, firing problems, and failure to obtain samples.
The affected devices were distributed worldwide, including in the United States, Australia, Canada, Europe, the Middle East, Africa, Latin America, and Asia Pacific. Healthcare providers should stop using the affected devices and contact Bard Peripheral Vascular Inc for further instructions.
The recalled product
- Product
- BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 727,034
Distribution
Distributed nationwide across the United States.
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