Last Updated on December 22, 2024 by The Health Master
Medical Device recall
Gastrointestinal (GI) bleed sufferers seeking minimally invasive treatment with Boston Scientific’s Obsidio Embolic device should be aware of a recent Medical Device recall classified by the U.S. Food and Drug Administration (USFDA) as “most serious” [High-Risk Medical Device Recall].
This classification indicates a high potential for patient harm.
What is the Problem?
The USFDA investigation revealed an increased risk of bowel ischemia when using the Obsidio Embolic with a specific delivery technique called the aliquot technique during lower GI bleed embolization procedures.
Bowel ischemia occurs when blood flow to the intestines is restricted, causing severe abdominal pain and potentially leading to serious complications like prolonged hospitalization or even death [Bowel Ischemia: Causes, Symptoms & Treatments].
What are the Details of the Medical Device Recall?
- This is a corrective action, not a product removal. The Obsidio Embolic itself remains available.
- The Medical Device recall involves 1,594 devices distributed between May 8, 2023, and February 8, 2024.
- There have been 11 reported incidents, including 7 injuries and 2 deaths, associated with this issue.
What Should You Do?
- Patients who have undergone a lower GI bleed embolization procedure using the Obsidio Embolic with the aliquot technique should consult their doctor immediately to discuss any potential risks.
- If you are considering this procedure, talk to your doctor about alternative methods that do not involve the aliquot technique.
Boston Scientific’s Response
On February 21, 2024, Boston Scientific issued an urgent advisory to healthcare providers, contraindicating the use of the aliquot technique with Obsidio Embolic for lower GI bleed procedures.
They maintain the device’s safety for its intended use with other delivery methods and for treating internal bleeding and hemorrhaging not related to the lower GI tract.
Key Takeaways
- The Obsidio Embolic device has a potential risk of bowel ischemia when used with the aliquot technique during lower GI bleed embolization procedures.
- Discuss alternative treatment options with your doctor if you are considering this procedure.
- The Obsidio Embolic remains available for its intended use with other delivery methods.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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