Boston Scientific’s Blood Flow Medical Device may cause Health Issues
Shub & Johns launches investigation into Boston Scientific after a recall on one of its devices used to block blood flow for hemorrhaging or excessive blood flow. The device, called Obsidio Embolic, poses a risk of bowel ischemia – a type of disorder that occurs when one’s intestinal blood flow decreases – when used with a specific method.
Boston Scientific issued an urgent medical device advisory in February 2024 that explained issues with the Obsidio Embolic when using a method known as the aliquot technique. The notice issued by Boston Scientific indicates that due to increased patient risk of hospitalization or death, Boston Scientific no longer recommended the aliquot technique’s use when using the Obsidio Embolic device. There have reportedly been approximately 11 incidents, with seven injuries and two deaths potentially caused by the increased risk of bowel ischemia associated with the device.
Since the notice of Boston Scientific’s Advisory recall, further investigation discovered that the device’s performance may be drastically altered when using the aliquot technique. In April 2024, the FDA classified the Obsidio Embolic recall as “most serious,” potentially posing an even greater threat to patients and consumers than expected.
Medical devices are manufactured to make medical procedures or surgeries safer for patients. This alleged defect with Boston Scientific’s Obsidio Embolic, however, brings about an increased risk of hospitalization or death for the patient. While the device remains in use for treatment, consumers should not be subject to potential health defects, hospitalization, or even death, when using a medical device that is meant to save them.
Have you or a loved one undergone a procedure using Boston Scientific’s Obsidio Embolic device? Were you made aware of the advisory recall or experienced any issues after the procedure? Let us know. Fill out the attached form to join the Shub & Johns investigation today!
