Hologic has initiated a recall of all lots of the disposable 9-gauge needles used in its Brevera Breast Biopsy System.
“The subject device is being removed because there is a risk of metal and plastic particles being dislodged from the device during use,” the company said in a voluntary urgent field safety notice sent to customers.
An internal review covering a three-year period during which 677,307 of the biopsy needles were shipped revealed 108 complaints related to the issue, with 16 confirmed cases of particles in patient breast tissue and/or tissue sample post biopsy; in one case, a procedure was aborted, Hologic said.
If particulate originating from the device is left behind in a patient post biopsy or if particulate enters a biopsy specimen, significant potential adverse events may occur, including foreign body reaction, hematoma, and infection, as well as a remote risk of vascular embolization, the company said.
Hologic is asking customers to quarantine any product units they currently have in inventory and to not use the product. The needles can be returned through IQVIA MedTech as part of the recall. The company can be reached at 1-757-601-9592, Hologic said.
