Sam Brusco, Associate Editor04.26.22
Medtronic has recalled its Harmony delivery catheter system, and the U.S. Food and Drug Administration (FDA) has deemed the recall as Class I.
Products distributed between April 7, 2021 and January 26, 2022 are affected by the recall, amounting to 665 devices in the U.S. Medtronic first began the recall on March 2. To date six complaints have been reported from clinical cases, one injury. No deaths have yet been reported.
The Harmony transcatheter pulmonary valve (TPV) system treats a leaky native or surgically repaired right ventricular outflow tract (RVOT)—the part of the heart that carries blood to the lungs. The Harmony TPV system is made up of a transcatheter pulmonary valve and delivery catheter, which is used to implant the replacement valve without open heart surgery.
It’s indicated for children and adults with severe pulmonary regurgitation requiring replacement of the pulmonary valve.
Medtronic recalled the Harmony delivery catheter because the bond holding the capsule at the end of the catheter may break during a procedure to place the TPV. This can cause procedure delays while the device is replaced or may require additional surgeries.
Further, a capsule bond break mi-procedure risks preventing blood flow, embolization and/or occlusion, tearing and/or splitting, or other types of damage to blood vessels.
Medtronic recommended immediate suspension of use for Harmony TPV’s delivery catheter beginning April 6.
Products distributed between April 7, 2021 and January 26, 2022 are affected by the recall, amounting to 665 devices in the U.S. Medtronic first began the recall on March 2. To date six complaints have been reported from clinical cases, one injury. No deaths have yet been reported.
The Harmony transcatheter pulmonary valve (TPV) system treats a leaky native or surgically repaired right ventricular outflow tract (RVOT)—the part of the heart that carries blood to the lungs. The Harmony TPV system is made up of a transcatheter pulmonary valve and delivery catheter, which is used to implant the replacement valve without open heart surgery.
It’s indicated for children and adults with severe pulmonary regurgitation requiring replacement of the pulmonary valve.
Medtronic recalled the Harmony delivery catheter because the bond holding the capsule at the end of the catheter may break during a procedure to place the TPV. This can cause procedure delays while the device is replaced or may require additional surgeries.
Further, a capsule bond break mi-procedure risks preventing blood flow, embolization and/or occlusion, tearing and/or splitting, or other types of damage to blood vessels.
Medtronic recommended immediate suspension of use for Harmony TPV’s delivery catheter beginning April 6.