The U.S. Food and Drug Administration (FDA) issued notice of supply chain interruptions for stereotactic breast biopsy needles due to recent supplier issues. Disruption in biopsy needle manufacturing is expected to impact patient care and could require adjustments for the management of patients requiring a breast biopsy. The agency noted that the duration of the biopsy needle shortage following a device recall is expected to continue through the end of the first quarter of 2027. As such, the FDA recommended that health-care providers consider and implement strategies for conserving existing supplies of stereotactic breast biopsy needles.
The manufacturing company Hologic issued a customer letter on January 2, 2026, stating that all of the Brevera Breast Biopsy System Disposable 9 Gauge Needles were being removed from the market due to a risk of metal and plastic particles getting dislodged from the device during its use, which could result in adverse effects if particulate matter get left behind in a patient after a biopsy. Such adverse effects could include foreign body reactions, hematoma/hemorrhage, and infections. Additionally, a subsequent biopsy could be necessary if particulate matter enter the biopsied specimen due to the potential for contamination.
On March 13, the FDA updated its Medical Device Shortages List to include stereotactic breast biopsy needles.
Agency Recommendations
The FDA recommends that health-care providers experiencing interruptions or shortages in stock of stereotactic breast biopsy needles should develop strategies to conserve the use of their supply. Providers should use their clinical judgment in the development and implementation of conservation strategies.
The agency recommended keeping the following tips and information in mind when developing individual supply conservation strategies:
Needle Conservation Strategies
- Expand supplier networks with vendor diversification
- Diversify and use all needle gauges and lengths to avoid dependence on limited inventory
- Utilize prior-generation devices where clinically appropriate
- Limit unnecessary opening/wasting of devices
Inventory and Supply Chain Management Tips
- Centralize inventory tracking across breast imaging sites
- Monitor inventory with a daily/weekly inventory dashboard available to all radiologists performing biopsy procedures
- Forecast utilization trends based on scheduled biopsy volumes and distribute biopsy needles appropriately across health systems/facilities
Patient Communication/Clinical Care
- Communicate delays transparently
- Offer alternative biopsy locations/sites where biopsy needles are available, if alternative devices are not suitable
- Maintain focus on minimizing delay for cancer diagnosis/treatment
FDA Actions
The FDA reviews each notification received under section 506J of the Federal Food, Drug, and Cosmetic Act and uses this information and any additional details about the supply of and demand for a device to determine whether a device is in shortage.
The agency is working with both manufacturers and providers to monitor the shortage situation to assist with the continued availability of stereotactic breast biopsy needles for clinically necessary situations. Additionally, the FDA is evaluating all potential solutions to mitigate the impacts on patient care and will inform the public as new information becomes available.
