• FDA Announces Class I Recall of Medtronic’s Harmony Catheter

    Medtronic’s announced recall of the Harmony delivery catheter for its Harmony Transcatheter Pulmonary Valve (TPV) System has been identified as a Class I recall, the most serious type, according to the U.S. Food and Drug Administration (FDA).

    The Harmony TPV System is used to treat a leaky native or surgically repaired right ventricular outflow tract. The device consists of a TPV and the Harmony delivery catheter. The system is indicated for us in children and adults who have severe pulmonary regurgitation and need a replacement pulmonary valve, according to the FDA’s recall announcement.

    Medtronic issued an Urgent Medical Device Recall notice on April 6 because it is possible that the bond holding the capsule at the end of the catheter might break during a TPV replacement procedure. A capsule bond break could cause procedure delays while the device is replaced with a new one, or it may mean the patient has to undergo additional surgeries, the FDA said.

    A capsule bond break during a procedure could also cause serious harm to the patient, including embolization or occlusion, perforation or dissection, or other damage to blood vessels, according to the announcement.

    The recall is specific to the delivery catheter itself, not the Harmony TPV. No actions are needed for patients who have already successfully been implanted with the Harmony TPV, the FDA said.

    There have been six reported complaints from clinical cases, one injury and no deaths associated with this device, according to the FDA.

    Problems may be reported to the FDA’s MedWatch adverse event reporting program. Customers with questions or concerns should contact Medtronic customer service at 1-800-854-3570.

    Image Credit: iQoncept – stock.adobe.com

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