Z-0816-2010

Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC...

Name: Z-0816-2010 Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC...
Creator: Baylis Medical Corp *
Published: 2010-02-08
License: https://open.fda.gov/license/

Baylis Medical Co., Inc. / initiated 2010-02-08 / Terminated / root cause: design

FDA source

Baylis Medical Corp * began a recall of Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1)... on 2010-02-08. The reason FDA records is "Radiopaque soft tip may fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0816-2010
Status: Terminated
Initiated: 2010-02-08
Posted: 2010-03-10
Terminated: 2010-09-13
Recalling firm: Baylis Medical Co., Inc.
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: Radiopaque soft tip may fracture.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 1,085 units (508 in US, 577 Foreign)
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 codes and lots: Lot Numbers: S21244, S21903, S21940, S22739 and S22739X1.

Product code DYB

K013919Class ITorflex Transseptal Guiding SheathBaylis Medical Co., Inc. / cleared 2002-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)