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FDA Issues a Class I Recall to Medtronic Harmony Transcatheter Pulmonary Valve System


April 27, 2022

According to a news article published on mddionline.com, Medtronic has issued another product safety recall.  The Dublin-based medical device manufacturer states that it has initiated a recall affecting certain lots of its Harmony Transcatheter Pulmonary Valve System.  The Food and Drug Administration stated that the recall is a Class I recall, since the product's defect could cause injury or death.  Class I recalls are the most severe type of recall.

Medtronic announced that the recall was initiated after it was discovered that the bond that holds the capsule at the tip of the Harmony Delivery Catheter may fracture during a surgical procedure to place the Transcatheter Pulmonary Valve TPV.  The FDA states that when the tip fractures, the patient will undergo additional surgeries. Moreover, when the capsule bond breaks, serious harm or death to the patient could happen.

The FDA also stated that there have been six incident reports from clinical cases, including one injury.  

Medtronic received FDA approval for the Harmony Transcatheter Pulmonary Valve (TPV) System back in March 2021. The Harmony Transcatheter Pulmonary Valve System provides a less invasive way to treat patients who have a surgically-repaired right ventricular outflow tract (RVOT).  

Medtronic has had multiple recalls over the past several months. If you or a loved one have been harmed by this or another medical device, contact our firm for your free case review.

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Source:

https://www.mddionline.com/regulations/medtronic-faces-yet-another-class-i-recall

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