ACR Mitigation Strategies for Breast Biopsy Needle Shortage

This article was updated Aug. 27, 2026, to include new information.

The American College of Radiology^® (ACR^®), with leadership and guidance from the ACR Commission on Breast Imaging, offers the following information for breast imaging physicians and their practices to mitigate patient care disruptions tied to a long-term shortage of stereotactic breast biopsy needles.

The shortage began earlier in 2026 after a major manufacturer stopped shipments to correct an issue. Limited alternatives had not fully met clinical demand. The FDA added the shortage to its Medical Device Shortages List, is actively working with industry to alleviate the issue and expects the shortage to last through Q1 2027 (subject to change). On June 16, with input from ACR and manufacturers, FDA published its notice, “Disruptions in Availability of Breast Biopsy Needles - Letter to Health Care Providers.” Most recently, the device manufacturer posted a regulatory status update in August 2026.

Radiology leaders should work closely with hospital systems, referring providers and patients to coordinate safe and effective care. Due to local factors, it may not be possible for individual practices to adopt all of these recommendations. 

Imaging providers should consult their legal counsel to ensure that steps outlined below meet any local, state or federal requirements and regulations. These mitigation strategies are suggestions and may not be applicable in all practices and situations.

Procedure Triage

• Increase targeted ultrasound utilization prior to any MRI/stereo biopsy as appropriate.
• Shift appropriate stereotactic and MRI biopsies to ultrasound-guided biopsies whenever feasible.
• Defer low-suspicion lesions to short interval follow-up when clinically appropriate.
• Reduce multisite stereotactic biopsies when clinically feasible.

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.
• Obtain the appropriate standard number of samples to avoid nondiagnostic results and need for re-biopsy.

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.

Prioritize cases:

• BI-RADS^® 5 lesions.
• Highly suspicious masses/calcifications.
• Neoadjuvant chemotherapy cases.
• Surgical planning cases.
• High-risk discordant lesions.

Consider delayed scheduling for:

• Low-suspicion BI-RADS 4A findings.
• If possible, use consensus reads, second read protocols, and/or panels for lesions that could be downgraded to a BIRADS 3 to allow short term follow-up instead of biopsy.
• Nonurgent repeat biopsies if possible.

Patient Communication/Clinical Care

• Communicate delays transparently.
• Offer alternative biopsy locations/sites where biopsy needles are available.
• Expedite surgical consultation when biopsy delay may impact care.
• Maintain focus on minimizing delay for cancer diagnosis/treatment.