FDA designates recall of pulmonary valve delivery catheter as class I
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Medtronic has announced a recall of the delivery catheter component in the company’s transcatheter pulmonary valve system due to risk for capsule break during use.
The FDA has designated the recall as class I, the most serious type of recall.
According to an FDA press release, the transcatheter pulmonary valve system consists of a transcatheter pulmonary valve and delivery catheter (Harmony Delivery Catheter System), used to implant a replacement valve without open heart surgery in children and adults with severe pulmonary regurgitation.
The bond holding the capsule at the end of the delivery catheter may break mid-procedure, risking procedural delays, additional surgeries and serious harm in the form of embolization, occlusion, perforation or dissection of the patient’s blood vessels, the FDA stated in the release.
The affected devices were distributed between April 7, 2021, and Jan. 26, 2022 and the recall applies to the delivery catheter only, according to the release.
There have been six complaints from clinical cases, one injury and no deaths associated with the delivery catheter, according to the agency.
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