FDA Warns of Critical Shortage of Stereotactic Breast Biopsy Needles Following Hologic Recall, Disruption Expected Through March 2027
核心洞察
The FDA has warned of a nationwide shortage of stereotactic breast biopsy needles expected to last until March 2027 due to a Hologic recall of its Brevera 9 Gauge Needle over contamination risks.
Hologic initiated the recall in January 2026 after reports of metal and plastic particles dislodging from needles, with 108 complaints identified among nearly 700,000 devices reviewed over three years.
The American College of Radiology has described the shortage as creating "immediate and substantial challenges" that represent a "patient safety and public health concern," particularly at high-volume and safety-net institutions.
The US Food and Drug Administration (FDA) has alerted healthcare providers to a significant disruption in the supply of stereotactic breast biopsy needles, a shortage expected to persist until March 2027. The agency attributed the interruption to "recent supplier issues" stemming from a recall by Hologic, a leading manufacturer of women's health imaging and diagnostic devices.
The shortage has raised urgent concerns across the breast imaging community, with the American College of Radiology (ACR) warning that the disruption represents "a broader patient safety and public health concern, particularly in high-volume centres and safety-net institutions where alternatives may be limited or unavailable."
Root Cause: Hologic Recall Over Particulate Contamination
Hologic stated on January 2, 2026, that all lots of its Brevera Breast Biopsy System (搜索) Disposable 9 Gauge Needle were being removed from the market due to a risk of metal and plastic particles dislodging from the devices during use. According to the FDA, if such particles are left behind during a biopsy, they could cause a foreign body reaction, hematoma or haemorrhage, or infection. Additionally, an additional biopsy may be necessary if particles enter a specimen.
The company conducted an internal review of nearly 700,000 needles over a three-year period and identified 108 complaints. The FDA has received approximately 20 adverse event reports since the start of 2026 related to Hologic's biopsy system. One woman reported a plastic piece sticking out of her biopsy site, while another returned to doctors five months after her biopsy to discover that a lump she felt was a 4-centimeter piece of plastic tube along the biopsy path. Other patients reported plastic beads emerging from their biopsy sites.
Hologic, which was acquired in April by funds managed by Blackstone Inc. (搜索) and TPG Inc. (搜索), said in a statement that it aims to bring the needles back on the market by the end of 2026. The company's breast-health business generates approximately $1.5 billion in sales annually. Hologic also indicated it would enable standalone imaging, increase supply of its other needle products, expedite product deliveries, and stabilize its inventory in the interim.
FDA Recommendations for Clinical Management
The FDA has issued guidance urging healthcare providers to develop conservation strategies for available stereotactic breast biopsy needles, prioritizing the highest-risk patients. The agency instructed providers to "use their clinical judgement" when implementing new strategies.
Specific needle conservation strategies recommended by the FDA include expanding supplier networks through vendor diversification, using all needle gauges and lengths to mitigate dependence on a single standard inventory, employing prior-generation devices where possible and clinically appropriate, and limiting unnecessary opening and wasting of needles.
For clinical care, the agency recommended that clinicians communicate delays to patients transparently, offer alternative biopsy locations where availability exists if other devices are not suitable, and maintain focus on minimizing delays for cancer diagnosis and subsequent treatment.
ACR Raises Alarm on Patient Impact
In a letter to the FDA in May, Dana Smetherman, CEO of the American College of Radiology, underscored the severity of the situation. "According to widespread reports from the breast imaging community, these shortages are creating immediate and substantial challenges for breast imaging practices nationwide, negatively impacting patient access to diagnostic care, and ultimately, to critical therapeutic intervention," Smetherman wrote.
The ACR formally requested that the FDA expedite the review of alternative or equivalent devices, increase communication and coordination with professional bodies, facilitate streamlined pathways for temporary importation of comparable biopsy devices, engage with manufacturers to prioritize production of essential biopsy supplies, and coordinate with relevant bodies to evaluate guidance on contingency planning or regional reserve approaches.
Broader Context: Hologic's Recall History
This is not the first time Hologic products have faced safety-related recalls. The company's BioZorb (搜索) implant was pulled in 2024 after hundreds of women reported the product failed to dissolve in their breasts, leading to infections and severe pain. The device was intended to help breast cancer (搜索) patients heal after a lumpectomy, but some women required additional surgeries and even mastectomies to resolve the harms. For years, Hologic did not report many of those complaints to the FDA despite federal law requiring notification within 30 days, according to previous reporting by Bloomberg.
The stereotactic biopsy needles at the center of the current shortage are used to take tissue samples from suspicious masses and are connected to a small vacuum that uses pressure to quickly remove tissue samples. Risks from particulate matter being left behind in patients include infection, delays in diagnosis, and interference with MRI scans, according to Hologic's customer letter from January.