Dozens of injuries trigger FDA recall of over 50,000 implantable tissue marking devices

The U.S. Food and Drug Administration has announced a Class I recall of over 50,000 soft tissue marker devices made by Hologic, Inc. 

The recall affects the BioZorb Marker and BioZorb LP Marker—devices that are implanted into soft tissue, often in the breast, to mark a region so that it can be easily identified during future medical procedures, like radiation therapy. 

The device includes two components—one that is made of titanium metal and is permanent, and one that is plastic and resorbs over time. 

The recall includes the following model numbers: 

  • F0405 BioZorb Marker 4cm x 5cm 

  • F0404 BioZorb Marker 4cm x 4cm 

  • F0331 BioZorb Marker 1cm x 3cm x 3cm 

  • F0231 BioZorb Marker 1cm x 3cm x 2cm 

  • F0221 BioZorb Marker 1cm x 3cm x 2cm 

  • F0304 BioZorb Marker 3cm x 4cm 

  • F0303 BioZorb Marker 3cm x 3cm 

  • F0203 BioZorb Marker 2cm x 3cm  

  • F0202 BioZorb Marker 2cm x 2cm 

The Class I recall, which is the most serious recall the FDA issues, comes after numerous reports of adverse events and complications linked to the radiographic markers.  

“Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device,” the FDA’s notice says. 

So far, 71 injuries related to the marker have been reported. 

Hologic sent a safety notification to affected customers in March. In that notice, Hologic advised patients who had already had the device implanted to monitor themselves for symptoms of an adverse reaction and report any complications to breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program. 

The recall is a correction, not a product removal. 

Read the full recall notice here

Hannah murhphy headshot

In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.

Around the web

Positron, a New York-based nuclear imaging company, will now provide Upbeat Cardiology Solutions with advanced PET/CT systems and services. 

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.