Urgent Recall Notice for Boston Scientific Obsidio Conformable Embolic

Urgent Class I Recall Notice  

Boston Scientific Corporation issued a critical recall notice on February 20, 2024, for its Obsidio Conformable Embolic products. The recall affects products distributed between May 8, 2023, and February 8, 2024.  

Product Details  

Obsidio Conformable Embolic is a premixed embolic agent intended for minimally invasive procedures to block blood flow in specific vessels, primarily used for embolizing hypervascular tumors or halting blood flow in peripheral blood vessels experiencing bleeding or hemorrhaging. 

Reason for Recall  

The recall was prompted by findings that utilizing the aliquot technique, a common delivery method in embolization procedures, poses a significant risk of bowel ischemia when used for lower gastrointestinal (GI) bleeding embolization. This complication can lead to serious consequences, including the necessity for major surgery such as bowel resection and potential fatalities. 

Adverse Incidents  

Reported incidents linked to this issue include eleven cases, comprising seven injuries and two fatalities. These outcomes underscore the urgency of addressing the problem and implementing appropriate measures to mitigate risks. 

Actions to Take  

Healthcare providers and facilities that have procured Obsidio Embolic are urged to immediately discontinue the use of the aliquot technique for lower GI bleed embolization procedures. Instead, alternative delivery methods should be employed to minimize the risk to patients. 

Boston Scientific issued an Urgent Medical Device Product Advisory to customers on February 21, 2024, outlining the recommended actions. This includes prominently displaying the advisory notice near the product for easy access by all users. 

Contact Information  

For inquiries related to this recall, affected parties are advised to contact their local Boston Scientific Representative promptly. Additionally, healthcare professionals and consumers can report adverse reactions or quality issues associated with these devices to MedWatch, the FDA Safety Information, and Adverse Event Reporting Program. https://www.accessdata.fda.gov/scripts/medwatch/index.cfm 

Conclusion  

The safety and well-being of patients undergoing vascular bleeding care are paramount. Immediate attention and adherence to the recall directives outlined by Boston Scientific are crucial to prevent further adverse incidents. Stay informed, take appropriate action, and prioritize patient safety above all else. 

Links 

Read the FDA recall announcement here.