International Medical Devices Database

Manufacturer Address
Baylis Medical Corp *, 5959 Trans-Canada Hwy, Montreal Canada
Source
USFDA
2 Events
- Recall of Device Recall Baylis Medical LumbarCool Pain Management System
- Recall of Device Recall TorFlex Transseptal Guiding Sheath

2 devices in the database

Device Recall Baylis Medical LumbarCool Pain Management System

Model / Serial
Lot Number: LKFA160310
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: TX
Product Description
The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 || The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.

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.

One manufacturer with a similar name

Learn more about the data here

Baylis Medical Corp *

Manufacturer Address
Baylis Medical Corp *, 5959 TransCanada Highway, Montreal Canada
Manufacturer Parent Company (2017)
Baylis Medical Company, Inc
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)