The embolic agent is being recalled over high risk of bowel ischemia during its delivery using the aliquot technique for lower gastrointestinal bleeding embolisation
A product shot of Obsidio Embolic. (Credit: Boston Scientific Corporation)
The US Food and Drug Administration (FDA) has identified Boston Scientific’s recall of Obsidio Conformable Embolic (Obsidio Embolic) as Class 1, the most serious kind of recall.
Obsidio Embolic is a premixed embolic agent, delivered minimally invasively to block blood flow to specific blood vessels.
The embolic agent is being recalled over a high risk of bowel ischemia during its delivery using the aliquot technique for lower gastrointestinal (GI) bleeding embolisation.
It is designed to embolise hypervascular tumours and to stop blood flow in peripheral blood vessels that are bleeding and/or hemorrhaging.
The most severe and frequently encountered adverse health consequence involves the necessity for major surgeries, such as bowel resection or diverting colostomy.
The FDA said that when using this product with the aliquot technique, there is a risk of impeding blood and oxygen flow to organs, including the small bowel, or causing non-target embolisation.
These complications can cause prolonged hospital stays, the need for additional surgical interventions, or even fatalities.
Boston Scientific has not suggested the aliquot technique for delivering Obsidio Embolic during lower gastrointestinal bleed embolisation procedures.
As of now, a total of 11 incidents have been reported, resulting in seven injuries and two deaths related to this issue.
According to the American health agency, healthcare providers who plan to use Obsidio Embolic can be affected along with patients with vascular bleeding who may receive care using Obisidio Embolic.
The medical technology company is recalling the product distributed between 8 May 2023 to 8 February 2024.
Currently, Boston Scientific has recalled 1,594 devices since it began the recall on 20 February 2024. On 21 February, the company issued an Urgent Medical Device Product Advisory to customers.
However, the FDA said that the recall is a correction, not a product removal.