Dive Brief:
- The Food and Drug Administration updated the recall notice for a Boston Scientific product that blocks blood flow.
- Boston Scientific recalled the product, Obsidio Conformable Embolic, in February in response to a problem then linked to seven injuries and two deaths. On Friday, the FDA updated its Class I recall notice, reporting an additional two deaths and eight injuries.
- The FDA provided the new information after Boston Scientific on Oct. 11 updated its instructions for use for the device, which stayed on the market after the recall. While the prior alert warned of risks for lower gastrointestinal (GI) bleeding, the revised instructions reflect evidence of risks when the product is used anywhere in the GI area.
Dive Insight:
Boston Scientific acquired Obsidio in 2022. The product is designed to block target blood vessels. Obsidio flows like a liquid when force is applied. When the force is removed, the agent returns to a soft solid state capable of blocking blood vessels. Boston Scientific identified the speed at which Obsidio blocks vessels as a differentiator in emergency situations such as GI bleeds.
While the company believes Obsidio has advantages over rival products such as liquid embolic agents, some physicians encountered problems when they began using the agent after its FDA authorization in 2022.
Boston Scientific initially saw risks when delivering Obsidio via the commonly used aliquot technique to treat lower GI bleeding. The company advised physicians against using Obsidio in that way in February in response to evidence of a high risk of reduced blood flow to the bowel.
Since then, Boston Scientific has identified risks associated with the use of Obsidio anywhere in the GI area. The new evidence informed an update to the instructions for use. Now, the company is advising against using the aliquot technique or pushing Obsidio with saline when performing embolization for any GI bleeding.
The product risks could cause off-target embolization and reduced blood and oxygen flow to organs, and “may lead to prolonged hospitalization, the need for additional surgery such as bowel resection or diverting colostomy, or death,” the FDA stated.
Boston Scientific warned physicians against making forceful injections in or near the Obsidio Embolic because they could change its properties and raise the risk of blocking off-target vessels. The company also updated the label to advise healthcare professionals to follow the revised instructions included in the recommended procedure section.
The FDA first posted a Class I recall notice in April and updated it late last week. As well as sharing Boston Scientific’s revised instructions, the agency updated the number of reports of patient harm. In total, there have been 15 injuries and four deaths related to the issue.