FDA classifies recall of Boston Scientific catheters as 'most serious'

The U.S. Food and Drug Administration on Wednesday classified a recall of Boston Scientific's catheters used in a type of minimally invasive surgery as "most serious". Read More

Boston Scientific catheters treating AFib with extreme cooling linked to 4 deaths: FDA alert

Devices already in inventory can be used with the updated instructions by doctors. Patients already treated don’t need to do anything. Read More

Boston Scientific updates cryoablation catheter instructions after 4 death reports

The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for atrial fibrillation. Read More

FDA elevates Boston Scientific cryoablation correction effort following four deaths

The FDA is elevating a recall from Boston Scientific covering its cryoablation balloon catheters for the treatment of atrial fibrillation. | No hardware is being removed from use—instead, the ... Read More

Boston Sci issues safety recall for POLARx cryoablation catheters

Boston Scientific (BSX) has issued a correction recall for its POLARx and POLARx FIT cryoablation balloon catheters over concerns that they may cause serious esophageal injuries. Read More

Boston Scientific recalls pacemakers at risk of triggering permanent safety mode

The FDA is boosting a recall effort from Boston Scientific regarding batteries potentially underpowering a number of the company’s implanted Accolade pacemakers, which may need to be repl | Boston ... Read More

Boston Scientific recalls catheters following 4 reported deaths

Boston Scientific has issued a recall for its POLARx Cryoablation Balloon Catheters after four deaths and seven reported injuries linked to astrio-esophageal fistulas, a severe complication during ... Read More

Boston Scientific pacemakers linked to 2 deaths are subject of FDA safety alert

The U.S. Food and Drug Administration has issued an urgent safety alert after an electric malfunction in some older Boston Scientific pacemakers was linked to two reported deaths and early device ... Read More

Boston Scientific warns on potential need to replace Accolade pacemaker devices early

The FDA today issued an alert after Boston Scientific warned of the potential need for the early replacement of certain pacemaker devices. Read More

FDA says Boston Scientific Accolade pacemakers may need early replacement

In a safety communication dated December 16 posted to the site of the FDA, the agency stated: “The U.S. Food and Drug Administration is ... Read More

FDA Issues Safety Communication for Some Accolade Pacemakers

Two pacing-dependent patients have died: an increased risk of permanently entering Safety Mode has been identified. Read More