Transseptal Sheath Kit Recall Issued Due to Particulate Matter Risk

A Class I recall has been issued for sheath kits used for safe catheterization in specific areas of the heart due to the potential risk of particulate matter migrating into the patient’s blood stream, posing serious and sometimes fatal injuries.

The TorFlex Transseptal Guiding Sheath Kit recall was announced by the FDA on September 23, after recognizing the potential for the sheath to extract particulate larger than 5mm from the dilator, potentially causing blockages if the particles enter the blood stream.

The Sheath Kits are a device that consists of a sheath, a dilator, and a J-tipped guide-wire used to provide safe catheterization and angiography in specific locations of the heart’s chambers.

The recall includes 1,035 Guiding Sheath Kits sold by Baylis Medical Company Inc., of Montreal, Canada that were manufactured between December 22, 2011 and July 24, 2013. For a full list of recalled part and lot numbers please visit here.

On September 23, Baylis Medical Company sent an “URGENT MEDICAL DEVICE RECALL” letter to all of their known customers with instructions to examine their inventory and to quarantine any affected kits. Customers should sign and return the medical device notice to Baylis by faxing it to (905) 602-5671.

Class I recall are considered the most dangerous because there is a reasonable probability that the use of the product will cause serious adverse health consequences and even death.

Customers with questions may also contact Baylis Medical Co. at (800) 850-9801 or by email at info@baylismedical.com. Healthcare professionals and customers are also encouraged to report any adverse health consequences in relation to the use of this product to FDA’s MedWatch Adverse Event Reporting Program by visiting them online at www.fda.gov/Safety/MedWatch/