FDA Hits Baylis Medical's TorFlex Transseptal Guiding Sheath Kit With Class I Recall

Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall - Sheath Could Remove Particulate

AUDIENCE: Cardiology, Risk Manager

ISSUE: FDA notified healthcare professionals of the Class 1 recall of TorFlex Transseptal Guiding Sheath Kit. The sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patient’s bloodstream.

BACKGROUND: The TorFlex Transseptal Guiding Sheath Kit is a single use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The components of the device include a sheath, a dilator and a J-tipped guidewire.

On Sept. 23, 2013 Baylis Medical Company sent an “URGENT DEVICE RECALL” letter to their customers. This recall covers 1,035 kits manufactured between 12/22/2011 and 07/24/2013. See list of affected lot numbers in Recall Notice.

RECOMMENDATION: Customers were instructed to examine their inventory and quarantine affected TorFlex Transseptal Guiding Sheath lots. Customers are then asked to sign and return a Medical Device Correction Acknowledgment Form directly to Baylis to their Fax number (905) 602-5671.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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