FDA now expects the U.S. shortage of stereotactic breast biopsy needles to continue through the end of March 2027.
The agency issued a June 16 letter to healthcare providers about the supply disruption. FDA said the shortage may affect patient care and may require changes in clinical management for patients indicated for breast biopsy.
The shortage involves stereotactic breast biopsy needles under product code KNW. FDA added the devices to its Medical Device Shortages List on March 13.
Brevera Breast Biopsy System Disposable 9 Gauge Needles are central to the disruption. FDA recall records show Hologic initiated a Class 2 recall for the device, with all lots within expiry affected.
FDA said Hologic’s January 2 customer letter stated that all lots of the Brevera 9 Gauge Needle were being removed because metal and plastic particles could dislodge from the device during use.
If particulate matter is left in tissue after biopsy, FDA said possible adverse effects include foreign body reaction, hematoma or hemorrhage, and infection. Specimen contamination could also require an additional biopsy procedure.
FDA is advising providers affected by shortages to conserve available needles. Suggested strategies include vendor diversification, use of different gauges and lengths, use of prior-generation devices when clinically appropriate, and centralized inventory tracking across breast imaging sites.
Patient-care recommendations include transparent communication about delays, use of alternative biopsy locations when suitable, and continued focus on minimizing delays in cancer diagnosis and treatment.
ACR had previously warned FDA about the shortage. In a May 14 update, the college said it had alerted federal officials to “patient care disruptions” tied to the shortage.
Hologic said it is targeting Brevera’s return to market by the end of calendar year 2026. The company said U.S. customers can use the Brevera system as a standalone specimen radiography system when the 9 Gauge biopsy needle is unavailable.
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