Devices

Device Recall TorFlex Transseptal Guiding Sheath

Model / Serial
Lot Numbers: S21244, S21903, S21940, S22739 and S22739X1.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Baylis Medical Corp *
1 Event
- Recall of Device Recall TorFlex Transseptal Guiding Sheath

Manufacturer

Baylis Medical Corp *

Manufacturer Address
Baylis Medical Corp *, 5959 Trans-Canada Hwy, Montreal Canada
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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