FDA designates Class 1 recalls for balloon catheters, radiographic markers

Editor's Note

Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18.

The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports of esophageal injury, especially atrio-esophageal fistula, prompted Boston Scientific to update use instructions to prevent serious patient risks, including cerebral air embolism, gastrointestinal bleeding, septic shock and death. Seven injuries and four deaths have been reported. The full FDA announcement offers specific models and UDIs of affected devices as well as additional instructions and recommendations for mitigating the risk.

The second recall involves Hologic, Inc.’s Biozorb Marker. Used to mark soft tissues (such as breast tissue) for future medical procedures, the product reportedly puts patients at risk of serious consequences including pain, infection, rash, device migration or erosion, seroma, and more. No deaths and 252 injuries have been reported. Among other recommendations, the FDA announcement specifies closely monitoring patients and avoiding further use of the product.