Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur through the right atrium.
FDA Recall Z-0816-2010 · Posted 2010-03-10
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Recalling FirmBaylis Medical Corp *
Recall StatusTerminated
Product CodeDYB
Date Initiated2010-02-08
Date Terminated2010-09-13
Product Quantity1,085 units (508 in US, 577 Foreign)
Reason for Recall
Radiopaque soft tip may fracture.
Firm Action
Baylis Medical Issued an "Urgent Medical Device Correction" letter via overnight courier beginning February 8, 2010. Consignees were instructed to segregate and return all affected product to the firm.
For further information, contact Baylis Medical Regulatory Scientific Affairs at 1-905-602-4875 Extension 252.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution -- United States, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Portugal, Qatar, Russia, Singapore, South Africa, Sweden, Switzerland, United Arab Emirates and the United Kingdom.
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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