Dive Brief:
- Boston Scientific has recalled an agent used to block blood flow to specific vessels due to a safety problem that has been tied to seven injuries and two deaths, the Food and Drug Administration said Wednesday in a recall notice.
- The company wrote to customers in February to advise against delivering the agent via a commonly used method in some patients because of a risk of reduced blood flow to the bowel.
- Boston Scientific’s product, Obsidio Conformable Embolic, remains on the market, but the company advised healthcare providers to ensure information on the risk is easily accessible to all users.
Dive Insight:
The solution flows like a liquid when force is applied, and then returns to a soft solid state when the force is removed. As a soft solid, the agent blocks blood vessels. Physicians use the product to block blood supply to tumors with large numbers of blood vessels and to treat patients who are bleeding.
Boston Scientific acquired the technology in 2022 to strengthen its interventional oncology and embolization portfolio. The takeover came one month after the FDA cleared the Obsidio agent for use.
The problem, which the FDA categorized as a Class I recall, relates to the use of the aliquot technique. The FDA said the technique is a commonly used delivery method in embolization procedures. However, there is a high risk of reduced blood flow to the bowel when physicians use the technique to deliver Obsidio to treat lower gastrointestinal bleeding.
Reduced blood flow to the organ, a condition known medically as bowel ischemia, can necessitate major surgery such as bowel resection and diverting colostomy. As such, the delivery of Obsidio using the aliquot technique can cause negative outcomes including prolonged hospitalization and death.
The FDA reported 11 incidents, seven injuries and two deaths related to the issue. To prevent further incidents, Boston Scientific told healthcare providers the aliquot technique is not recommended for lower gastrointestinal bleed embolization procedures with Obsidio because of the increased risk to the patient.
The company asked customers to post its recall notice near the product.
