Baylis Medical TorFlex Transseptal Guiding Sheath — Class I medical device recall Z-0085-2014
Terminated recall by Baylis Medical Corp *, reported 2013-11-13, distributed nationwide. The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could re
| Recall number | Z-0085-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baylis Medical Corp *, Montreal, N/A, Canada |
| Recall initiated | 2013-09-23 |
| Classified | 2013-11-01 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2015-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, IT, SA |
| Quantity | 370 devices |
| Reason classes | specification failure |
| Lot numbers | TFFA051212, TFFA070213, TFFA070912, TFFA201212, TFFA221211, TFFA230113, TFFA230812, TFFA250512, TFFA280912, TFFA290113, TFFA290812, TFFA310812, TFFB070612, TFFB070912, TFFB221211, TFFB230113, TFFB230812, TFFB280912, TFFB290113, TFFB310812, TFFC051212, TFFC070912, TFFC221211, TFFC230812, TFFC260413, TFFC280213, TFFC280912, TFFD070912, TFFE070912, TFFF070213, TFFF070912, TFFG070912, TFFH070912 |
| Model numbers | TF8-32-63-135, TF8-32-63-37, TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-81-135, TF8-32-81-37, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF8-38-62-S, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-81-135, TF85-32-81-37, TF85-32-81-90 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0085-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.