Healthcare
No matter how we manage our health, efficacy, risks and costing are top concernsRecalled of medical devices due to high risk of heart problem or even death, Transseptal Sheath Introducer Kit
Recent alert from FDA, related to the safety of medical device of Transseptal Sheath Introducer Kits from Thomas Medical products marketed as HeartSpan, Torflex, CHANNEL FX, and Braided Guiding Introducer Kit, that the tip of those devices may break off and embolize while the sheath is in the coronary artery.
Due to this, patient could get open heart surgery, heart attack or related to myocardial infarction (MI), stroke, or even death risk.
In medical treatment, the sheaths of this device used to pass cardiac catheters from the right to the left of the heart through the septum.
Product recalled which distributed between October 1, 2006 to December 28, 2009.
The FDA and the product company urge the distributor to stop distributing and return it to the Thomas Medical Products, Inc.
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