June 16, 2026
The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of stereotactic breast biopsy needles because of recent supplier issues. The manufacturing disruption in supply of these devices is expected to impact patient care and may require adjustments to the clinical management of patients indicated to undergo a breast biopsy. The FDA currently expects the duration of this shortage to extend through the end of Q1 (March) 2027. The FDA recommends health care providers consider strategies to conserve the use of stereotactic breast biopsy needles.
On January 2, 2026, Hologic issued a customer letter stating that all lots of the Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed because there is a risk of metal and plastic particles being dislodged from the device during use. If particulate matter originating from the device is left behind in a patient post-biopsy, potential adverse effects such as foreign body reaction, hematoma/hemorrhage, and infection may arise. If particulate matter enters a biopsy specimen, an additional biopsy procedure may be required due to contamination of the specimen.
Recommendations
The FDA recommends health care providers experiencing interruptions or shortages in supply of stereotactic breast biopsy needles develop strategies to conserve their use. Providers should use their clinical judgment when developing and implementing conservation strategies.
In developing strategies to preserve the supply for patients at highest risk, please consider the following:
Needle Conservation Strategies
- Expand supplier networks with vendor diversification.
- Diversify and utilize all needle gauges and lengths to avoid dependence on limited “standard” 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 biopsy devices are not suitable.
- Maintain focus on minimizing delay for cancer diagnosis/treatment.
Background
On March 13, the FDA updated the Medical Device Shortages List to include stereotactic breast biopsy needles (product code KNW). Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the devices the FDA has determined to be in shortage.
FDA Actions
The FDA is:
- Working with manufacturers and providers to monitor the current situation to help ensure stereotactic breast biopsy needles remain available for patients when medically necessary.
- Evaluating potential solutions for mitigating patient impact.
- Informing the public as new information becomes available.
The FDA reviews each notification received under section 506J of the FD&C Act and uses this information, along with any additional details about the supply of and demand for a device, to determine whether the device is in shortage.
Reporting Problems to the FDA
The FDA encourages health care providers to report any supply chain challenges or suspected adverse events experienced with stereotactic breast biopsy needles.
By promptly reporting device availability issues and potential shortages, you can help the FDA understand the scope of the problem, and, when possible, mitigate the issue.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
Additional Resources
- ACR Mitigation Strategies for Breast Biopsy Needle Shortage
- Hologic Update on Brevera Biopsy Needle Availability
- Hologic Update on Eviva Breast Biopsy System
Article source: http://www.fda.gov/medical-devices/letters-health-care-providers/disruptions-availability-breast-biopsy-needles-letter-health-care-providers