Recall of Boston Scientific Balloon Catheters Identified by FDA as Most Severe Type

The FDA has identified a Boston Scientific recall of certain cryoablation balloon catheters as the most serious type.

The products affected are the POLARx Cryoablation System and the POLARx and POLARx FIT Cryoablation Catheters and SMARTFREEZE Cryo-Console.

The products carry a “known and inherent risk of esophageal injury, including atrio-esophageal fistula, that may occur during catheter-based ablation procedures for rapid, irregular heartbeats (atrial fibrillation).” Boston Scientific recommends that affected customers “review instructions for use updates related to atrial esophageal fistulas.” The IFUs have been updated to include recommendations that minimize the risk for potential esophageal injury and unintended thermal injury.

As it stands, use of affected product “may cause serious adverse health consequences, including atrio-esophageal fistula leading to air bubbles blocking blood vessels in the brain (cerebral air embolism), stomach and intestinal (gastrointestinal) bleeding, a system-wide infection (septic shock), and death. There have been seven reported injuries. There have been four reports of death.”

The “Boston Scientific Cardiac Cryoablation System using POLARx Cryoablation Balloon Catheters is indicated for the treatment of recurrent, symptomatic atrial fibrillation, which leads to irregular, fast heartbeats that resolve within seven days (paroxysmal) that do not respond to medication (drug-refractory).”