Medtronic Harmony Delivery Catheter Recall Issued Following Reports of Capsule Breaking

Hundreds of Medtronic Harmony delivery catheters are being recalled because the end of the catheter may break off during insertion, resulting in serious and potentially life-threatening adverse health consequences for patients.

The FDA announced the Medtronic catheter recall on April 26, warning that the bonding on the capsule at the end may break during valve replacement surgery among children and adults.

To date, Medtronic has received at least six reports of the capsules breaking away from the catheter, resulting in at least one injury. Although no deaths have been reported, the FDA is warning healthcare professionals to stop using the devices immediately to prevent further injuries, or fatal outcomes.

The recall impacts Harmony Transcatheter Pulmonary Valve (TPV) Systems, which consist of a transcatheter pulmonary valve and a delivery catheter. The devices are used on children and adults who suffer from severe pulmonary regurgitation, which is a condition that causes blood to flow backwards from the right ventricular outflow tract into the right lower chamber of the heart.

Patients with pulmonary regurgitation are often required to undergo surgery to replace the pulmonary valve. The Harmony Delivery Catheter is used to implant the replacement valve without open heart surgery.

According to the recall, if the catheter’s capsule breaks during placement of the replacement valve, patients could experience delays while the device is replaced with a new catheter, or require additional surgeries to retrieve the separated catheter tip. Officials warn patients could also experience severe or life threatening harm if the catheter capsule blocks blood flow or damages the patient’s blood vessels.

Approximately 665 Harmony Delivery Catheters sold as part of the Harmony Transcatheter Pulmonary Valve (TPV) System are included in the recall. The recalled catheter systems were distributed to healthcare facilities and hospitals from April 7, 2021 through January 26, 2022.

Medtronic issued an Urgent Medical Device Recall notice of April 6, instructing physicians and customers to immediately suspend the use of the Harmony TPV’s delivery catheter. The notice instructed customers to remove all unused products from inventory and return them to Medtronic.

The recall notice instructs customers with recalled devices are being asked to fill out the form enclosed in the letter and to report the number of devices currently in inventory to arrange a return. Those with additional questions or concerns regarding the recall are being asked to contact Medtronic Customer Service at 800-854-3570 and to report any adverse reactions or quality problems to the FDA’s MedWatch, Adverse Event Reporting Program.

Catheter Tip Detachment Recalls

In recent years, the FDA has issued dozens of catheter recalls over various manufacturing defects causing the tips of catheters to break off during procedures. Most of the recalls have been classified as a Class I recall by the FDA, indicating they are the most serious of their kind, and that the use of the products carry a high probability of severe patient injury or death.

One of the most recent Medtronic catheter recalls was issued in March, involving several hundred Medtronic TurboHawk catheters which may fail if the guidewire within the catheter prolapses or move downward under the application of force during normal use.

In January 2021, a Penumbra Jet 7 Reperfusion Catheters with Xtra Flex Technology recall was announced by the FDA, impacting nearly 31,000 units due to distal tip damage and separation issues. The recall was issued after more than 200 medical device reports involving problems with Penumbra JET 7 Xtra Flex catheters involving serious injuries were submitted. The reports included at least 14 patient deaths.