Applied Medical is recalling several models of catheters due to a risk that its catheter tips will detach during use. Catheter separation could lead to serious adverse health consequences and even death. The U.S. Food and Drug Administration has labeled this a Class I recall, its most serious designation reserved for products that pose a reasonable probability of severe injuries or death.
The full text of the FDA recall announcement can be found here.
Which Applied Medical Catheters Are Affected by the Recall?
The extensive recall affects 19,400 Applied Medical Catheters distributed in the United States between July 23, 2015 and March 1, 2019. The recalled models are the Python Embolectomy Catheters, the Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters. All three models are latex balloon catheters designed to temporarily block veins and arteries and deliver liquids into the patients’ bloodstream during various procedures. Unfortunately, there have been multiple reports of these catheters separating during use. If the tip detaches from the catheter’s body during use, pieces of the catheter could break off into the patient’s body. The fragments – or attempts to remove the fragments – could result in vein or artery blockage, injury to vein or artery walls, blood clots, embolism, heart attack, and death. Further, a catheter separation could require a patient to undergo an additional surgical procedure to remove the detached fragment from his or her body.
If you or a loved one have suffered injuries you believe were caused by an Applied Medical catheter, contact one of the experienced medical device attorneys at Burg Simpson today. Our compassionate lawyers possess the knowledge and resources to investigate your potential claim, and to seek justice and compensation for your injuries. We would be happy to discuss your potential claim. Call 513-852-5600, or fill out our contact form for a FREE no-obligation consultation today.