Critical Update for Medical Device Use: Boston Scientific Issues New Guidelines for Safe Application of Obsidio Embolic in GI Procedures
Marlborough, Massachusetts — In a significant update, Boston Scientific has issued new guidelines for the use of its Obsidio Embolic devices, distributed to over 1,500 customers since May 2023. The recall, classified as Class I, which is used for serious or life-threatening product defects, surprisingly does not require the return of any devices. Instead, the company has asked health professionals to heed revised instructions aimed at ensuring patient safety during gastrointestinal bleeding embolization procedures. The …