A medical device used to pass catheters through the heart is being recalled by the manufacturer because the tip of the device may break off while the sheath is in the blood vessels, which could lead to serious injury or death. The Food and Drug Administration notified health care professionals this week of the Class 1 recall on Thomas Medical Products Inc., Transseptal Sheath Introducer Kits. Class 1 recalls are the most serious type of recall issued by the FDA and involve situations in which there is reasonable probability that use of the products will cause serious adverse health consequences or death.
The sheaths are used to pass heart catheters from the right to the left side of the heart by crossing the middle heart wall, or septum. The devices are being recalled because the sheath tip may break off and separate while the sheath is in the blood vessels. If this occurs, the fragment could move through the heart and arteries to vital organs causing a blockage anywhere, including the brain or the heart. This could lead to unplanned open-heart surgery, permanent injury from stroke or heart attack, and/or death.
To date, Thomas Medical Products has received five adverse event reports in which the transseptal sheath introducer tip became fragmented or separated. The issue caused no clinical problems in four of the cases, however in one case the tip fragment embolized in a coronary artery.
The device’s manufacturer sent notices about the recall to its customers and is arranging for the return of all unused products. Health care professionals and consumers are encouraged to report any adverse reactions or quality problems with this or any other medical device to the FDA’s MedWatch Adverse Event Reporting program at www.FDA.gov/MedWatch.