Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: Obsidio Conformable Embolic
- Product Codes: See Medical Device Recall Database Entry
- Distribution Dates: May 8, 2023 to February 8, 2024
- Devices Recalled in the U.S.: 1,594
- Date Initiated by Firm: February 20, 2024
Device Use
The Obsidio Conformable Embolic (Obsidio Embolic) is a premixed embolic agent that is delivered minimally invasively to block (occlude) blood flow to specific blood vessels. After injection, Obsidio Embolic creates a solid cast in the vessel and halts blood flow. It is intended for single use to embolize hypervascular tumors and to occlude blood flow in peripheral blood vessels that are bleeding and/or hemorrhaging.
Reason for Recall
Boston Scientific Corporation is recalling Obsidio Embolic by issuing a correction. An investigation determined that delivery of Obsidio Embolic using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal (GI) bleeding embolization poses a high risk of bowel ischemia.
The most serious and the most common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy. Use of this product with the aliquot technique may prevent blood and oxygen flow to organs including the small bowel (ischemia) or non-target embolization, all of which may lead to prolonged hospitalization, the need for additional surgery or death.
Boston Scientific does not recommend that the aliquot technique be used to deliver Obsidio Embolic for lower GI bleed embolization procedures.
There were 11 incidents reported, seven injuries, and two deaths related to this issue.
Who May be Affected
- Health care providers who plan to use Obsidio Embolic to embolize vascular bleeding.
- Patients with vascular bleeding who may receive care using Obisidio Embolic.
What to Do
On February 21, 2024, Boston Scientific issued an Urgent Medical Device Product Advisory to customers. This notice explained that use of the aliquot technique is not recommended for lower GI bleed embolization procedures with Obsidio Embolic due to the increased risk to the patient.
Recommended actions for customers:
Immediately post the notice near the product to ensure the information is easily accessible to all users.
Contact Information
Customers with questions about this recall should contact their local Boston Scientific Representative.
Additional Resources
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.