Medical equipment company Medtronic issued a recall of its Harmony Delivery Catheter System, which can break during surgery and cause procedure delays, additional surgeries and/or serious harm to a patient. The U.S. Food and Drug Administration identified this as a Class I recall, the most serious classification, because use of the recalled devices may result in serious injuries or death.

The breakage may occur at the bond holding the capsule at the end of the delivery catheter during a procedure to place the Transcatheter Pulmonary Valve (TPV) System in a patient, according to the recall. A broken bond may prevent blood flow and/or completely block, tear and/or split the patient’s blood vessels.

The recall is specific to the Harmony Delivery Catheter only and not the Harmony TPV, the recall notice says. Patients who have already been successfully implanted with a Harmony TPV are unaffected by the recall. 

Six complaints from clinical cases have been reported in relation to this recall, as well as one injury. No deaths have been associated with the use of a Harmony Delivery Catheter System.

Two main groups should be aware of the Medtronic catheter recall: health care workers who are involved with TPV implants and patients who are candidates for valve replacement. The TPV is approved for use in children and adults who require replacement of the pulmonary valve.

In the United States, Medtronic has recalled 665 devices that were distributed from April 7, 2021, to Jan. 26, 2022.

Medtronic instructs customers to remove all unused products from use and return them to Medtronic, as well as pause any new clinical cases involving the Harmony TPV System.

Customers who received a Medtronic recall letter should also complete a form confirming their receipt of the recall and reporting the number of unused devices they have. 

Customers with questions or concerns about the Harmony catheter recall should contact Medtronic Customer Service at 800-854-3570. Adverse reactions or other issues can also be reported to FDA MedWatch through an online form, regular mail or fax. 

If you are a patient or medical professional involved in Harmony TPV procedures, follow Medtronic’s recall instructions. Check back with TCA for any additional updates!

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Medical equipment company Medtronic issued a recall of its Harmony Delivery Catheter System, which can break during surgery and cause procedure delays, additional surgeries and/or serious harm to a patient. The U.S. Food and Drug Administration identified this as a Class I recall, the most serious classification, because use of the recalled devices may result in serious injuries or death.... Read More

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