Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
FDA Recall Z-0085-2014 · Posted 2013-11-01
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Recalling FirmBaylis Medical Corp *
Recall StatusTerminated
Product CodeDYB
Date Initiated2013-09-23
Date Terminated2015-03-31
Product Quantity370 devices
Reason for Recall
The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.
Firm Action
Baylis Medical sent an Urgent Device Recall Notification letter dated September 23, 2013, via overnight courier to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the response form provided and fax to 905-602-5671 ATTN: Quality Department to arrange for a free of charge replacement of the affected product. The form requires consignees to return the affected product. For questions contact Quality Assurance at 800-276-4416.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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