The FDA has warned healthcare professionals of a class 1 recall regarding the Baylis Medical Torflex Transseptal Guiding Sheath after it found that the sheath tip has the potential to break off and separate during cardiac procedures.
According to the FDA, the unattached sheath tip could potentially cause blockages that could produce adverse events such as stroke, heart attack or death.
The recall incorporates the devices, used to pass heart catheters from each side of the heart, manufactured between April 11, 2007, and March 3, 2008, and distributed between April 2007 and May 2009.
Included in the recall are: model numbers TF8-38-62-S and lot numbers S21244, S21903, S21940, S22739 and S22739X1.
The agency suggests that healthcare professionals using the device stop and are asked to return unused products to Montreal-based Baylis, and return the acknowledgment form.
In addition, the FDA asks all consumers who have witnessed adverse reactions or effects to report them to the FDA’s MedWatch reporting program.