By David C. Harman, Burg Simpson Shareholder
Cook Medical Recalls Dangerous Transseptal Needle
On March 13, 2019, The U.S. Food and Drug Administration (FDA) announced that Cook Medical Inc. sent an urgent recall notification letter to affected customers regarding its Transseptal Needle. Cook Medical’s Transseptal Needle is a surgical device used to gain access to the left side of a patient’s heart during both diagnostic and interventional cardiac procedures. The recall affects one lot, or 97 devices, that were manufactured without a back bevel on the needle tip.
The manufacturing error poses a significant health risk to patients. The absence of a back bevel creates a sharp needle tip that could damage the inside of the introducer during needle insertion, resulting in detached plastic fragments. The detached plastic fragments could then enter the patient’s bloodstream and lead to serious health consequences, including but not limited to surgical removal of the plastic pieces, damage to blood vessel walls, stroke, and even death. Indeed, the FDA has identified the recall as a Class I recall, which is the most serious type and denotes that use of these devices may cause serious injuries or death.
If you or a loved one has suffered injuries from a cardiac procedure using Cook Medical’s Transseptal Needle, contact one of the experienced product liability attorneys at Burg Simpson’s Cincinnati office today. Our award-winning attorneys would be happy to discuss your potential claim. Call 1-513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.