Baylis Medical Corp *: 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.

Recall number

Z-0085-2014

Recalling firm

Baylis Medical Corp *

Product

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.

Status

Terminated

Initiated

2013-09-23

Posted

2013-11-01

Terminated

2015-03-31

Reason

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.

Root cause

Component design/selection

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.

Quantity

370 devices

Distribution

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.

Lot, serial or model codes

Part No. TF8-32-63-135, Lot TFFB070912; Part No.TF8-32-63-37, Lot TFFA310812; Part. No. TF8-32-63-37, Lot TFFB290113; Part No. TF8-32-63-45, Lot TFFA290113; Part No. TF8-32-63-45, Lot TFFB310812; Part No. TF8-32-63-45, Lot TFFC221211; Part No. TF8-32-63-55, Lot TFFA051212; Part No. TF8-32-63-55, Lot TFFA230812; Part No. TF8-32-63-55, Lot TFFB221211; Part No. TF8-32-63-55, Lot TFFB230113; Part No. TF8-32-63-90, Lot TFFA070213; Part No. TF8-32-63-90, Lot TFFA070912; Part No. TF8-32-81-135, Lot TFFH070912; Part No. TF8-32-81-37, Lot TFFD070912; Part No. TF8-32-81-45, Lot TFFE070912; Part No. TF8-32-81-55, Lot TFFF070912; Part No. TF8-32-81-90, Lot TFFG070912; Part No. TF8-38-62-S, Lot TFFA201212; Part No. TF85-32-63-37, Lot TFFC070912; Part No. TF85-32-63-45, Lot TFFA221211; Part No. TF85-32-63-45, Lot TFFA250512; Part No. TF85-32-63-45, Lot TFFC051212; Part No. TF85-32-63-45, Lot TFFC230812; Part No. TF85-32-63-55, Lot TFFA230113; Part No. TF85-32-63-55, Lot TFFA290812; Part No. TF85-32-63-55, Lot TFFB070612; Part No. TF85-32-63-90, Lot TFFB230812; Part No. TF85-32-63-90, Lot TFFC260413; Part No. TF85-32-63-90, Lot TFFC280213; Part No. TF85-32-63-90, Lot TFFF070213; Part No. TF85-32-81-135, Lot TFFC280912; Part No. TF85-32-81-37, Lot TFFA280912; and Part No. TF85-32-81-90, Lot TFFB280912

510(k) numbers

["K102948"]

PMA numbers

not on file

Product code

DYB

Firm FEI

3005241199

Firm city

Montreal

Firm state

not on file

Firm country

Canada

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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