TERUMO MEDICAL RECALLS SURGICAL DEVICES OUT OF FEAR OF VASCULAR DAMAGE, EVEN DEATH
On April 26, 2019, Terumo Medical Corporation voluntarily recalled two of its surgical devices, the SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access System (SR). Both devices were designed to help surgeons safely and easily introduce and/or guide the placement of medical devices into a patient’s arteries. However, the smooth tips of the guiding systems have been found to slightly separate or bend from the sheath they are intended to protect, resulting in a rougher insertion process.
On May 29, 2019, the U.S. Food and Drug Administration (“FDA”) classified Terumo Medical’s recall of the medical systems as a Class I recall, a designation reserved for situations in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. The FDA’s Recall Announcement identifies a multitude of scary injuries that can result from the use of the recalled products, including but not limited to vessel tears, hemorrhage, and blood between the two outer layers of an artery (pseudoaneurysm). The aforementioned complications may necessitate additional medical intervention, prolong the surgery, and can even lead to death. Indeed, the FDA confirms that the firm has received at least 14 reports of malfunctioning systems, two of which resulted in serious vascular damage.
The recall affects 3,474 devices that were distributed to medical professionals in the U.S. between July 22, 2016 and March 13, 2019.
If you or a loved one have suffered surgical complications or injuries that you believed were caused by the Terumo Medical systems, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.