Boston Scientific has initiated a recall of its Obsidio Conformable Embolic device due to an increased risk of bowel ischemia when used for lower gastrointestinal (GI) bleeding embolisation procedures.

The US Food and Drug Administration (FDA) has classified this as a Class I recall, indicating the potential for serious injury or death.

Boston Scientific has reported 11 related incidents, including seven injuries and two deaths.

A premixed embolic agent, the Obsidio Embolic is designed for single usage to embolize hypervascular tumours as well as to occlude blood flow in peripheral blood vessels that are haemorrhaging or bleeding.

The product was distributed between 8 May 2023 and 8 February 2024. A total of 1,594 devices have been recalled in the US.

The recall follows the completion of Boston Scientific’s investigation that revealed the use of the aliquot technique for lower GI bleeding embolisation could lead to a high risk of bowel ischemia. This technique is commonly employed in embolisation procedures.

Boston Scientific Corporation recalled the device by issuing a correction. 

According to the FDA, the use of the Obsidio Embolic with the aliquot technique could obstruct blood and oxygen flow to organs, leading to ischemia or non-target embolization.

These complications may result in prolonged hospital stays, additional surgeries, or even death.

Recently, Boston Scientific commenced a clinical study of its FARAVIEW software module, used in conjunction with its FARAWAVE Nav pulsed field ablation (PFA) catheter to treat both paroxysmal and persistent atrial fibrillation.

The FARAWAVE Nav PFA catheter integrates magnetic navigation into the existing FARAWAVE PFA catheter, allowing comprehensive mapping and PFA therapy in one device.