On September 23, 2013 Montreal, Canada-based Baylis Medical Company sent an urgent device recall letter to its customers.
As reported by the U.S. Food and Drug Administration (FDA) on November 6, 2013, the Class I recall affects 1,035 TorFlex Transseptal Guiding Sheath Kits that were manufactured between December 22, 2011 and July 24, 2013 (part and lot numbers reported below).
Class I recalls are reserved for such situations in which there is a reasonable probability that the product will cause serious adverse health consequences or death.
The sheath kit is a single use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The components include a sheath, a dilator, and a J-tipped guide wire.
According to the FDA, the kit has been recalled because the sheath could remove particulate of less than 5 mm from the dilator. The particulate could then potentially migrate into the patient’s bloodstream.
Baylis has instructed customers to examine their inventory, quarantine affected lots, and sign and return a Medical Device Correction Acknowledgment Form directly to the company.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program.
Possible thoughts on the design flaw? Comment below.
Part Lot Number
TF8-32-63-90 TFFA070213
TF8-32-63-90 TFFA070912
TF8-32-81-135 TFFH070912
TF8-32-81-37 TFFD070912
TF8-32-81-45 TFFE070912
TF8-32-81-55 TFFF070912
TF8-32-81-90 TFFG070912
TF8-38-62-S TFFA201212
TF85-32-63-37 TFFC070912
TF85-32-63-45 TFFA221211
TF85-32-63-45 TFFA250512
TF85-32-63-45 TFFC051212
TF85-32-63-45 TFFC230812
TF85-32-63-55 TFFA230113
TF85-32-63-55 TFFA290812
TF85-32-63-55 TFFB070612
TF85-32-63-90 TFFB230812
TF85-32-63-90 TFFC260413
TF85-32-63-90 TFFC280213
TF85-32-63-90 TFFF070213
TF85-32-81-135 TFFC280912
TF85-32-81-37 TFFA280912
TF85-32-81-90 TFFB280912
