Medtronic is recalling the Harmony Delivery Catheter, part of the Transcatheter Pulmonary Valve (TPV) System, due to the risk of capsule rupture during use

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can result in serious injury or death.

Recalled product

  • Product Name: Harmony Delivery Catheter System
  • Product codes and batch numbers: see database entry.
  • Distribution dates: April 7, 2021 to January 26, 2022
  • Devices recalled in the United States: 665
  • Company Initiation Date: March 2, 2022

Use of the device

The Harmony Transcatheter Pulmonary Valve (TPV) System is used to treat a native or surgically repaired right ventricular outflow tract (RVOT), which is the part of the heart that carries blood to the lungs. The Harmony TPV System consists of a transcatheter pulmonary valve and a delivery catheter, the Harmony Delivery Catheter, which is used to implant the replacement valve without open heart surgery.

The system is indicated for use in children and adults who have severe lung regurgitation, which is when blood refluxes from the RVOT into the lower right chamber (right ventricle) of the heart and requires replacement of the pulmonary valve.

Reason for recall

Medtronic is recalling the Harmony Delivery Catheter because the bond that secures the capsule to the tip of the delivery catheter may break during a TPV placement procedure.

Breaking the capsule bond could cause delays in the procedure while the device is being replaced with a new one or require the patient to undergo additional surgeries. Additionally, a rupture of the capsule bond when using it during a procedure could cause serious harm to the patient. These risks include obstruction of blood flow and/or complete blockage (embolization or occlusion), tearing and/or separation (perforation or dissection), or other types of damage to the patient’s blood vessels.

There have been 6 reported clinical case complaints, one injury, and no fatalities associated with the use of these devices.

Who can be affected

  • Healthcare personnel who plan to implant the Harmony TPV in patients with severe pulmonary insufficiency
  • Individuals who are candidates for valve replacement using the Harmony TPV System

What to do

On April 6, 2022, Medtronic issued an Urgent Medical Device Recall Notice to implanting physicians and customers recommending immediate suspension of use of the Harmony TPV Delivery Catheter.

Instructions for customers included:

  • Remove all unused products from use and return them to Medtronic.
  • Suspension of new clinical cases involving the Harmony TPV System.

Customers were also asked to complete a form attached to the letter to confirm receipt of the recall and report the number of unused devices currently on hand.

The letter also stated that the recall is:

  • Specific to the Harmony Delivery Catheter only, not the Harmony TPV.
  • The rupture only occurred in the delivery catheter during placement of a TPV, no action is necessary for patients who have already been successfully implanted with a Harmony TPV.

Contact information

Customers with questions or concerns regarding this recall should contact Medtronic Customer Service at 800-854-3570.

Additional Resources:

How do I report a problem?

Healthcare professionals and consumers can report adverse reactions or quality issues they have experimented with using these devices for MedWatch: the FDA’s Safety Information and Adverse Event Reporting Program using an online form, mail, or fax .

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