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Medtronic Faces Yet Another Class I Recall

Image courtesy of Sundry Photography / Alamy Stock Photo IMG_2022-4-27-082415.jpg
Medtronic said the recall impacts delivery catheters used with the Harmony transcatheter pulmonary valve system.

Medtronic continues to grapple with recalls. The Dublin-based company said that it was recalling delivery catheters used with the Harmony transcatheter pulmonary valve system. FDA classified it as a Class I recall, the most serious type.

Medtronic is recalling the Harmony Delivery Catheter because the bond holding the capsule at the end of the delivery catheter could break during a procedure to place the TPV. 

In a release, FDA said a capsule bond break could cause procedure delays while the device is replaced with a new one or it may require the patient to undergo additional surgeries. Additionally, a capsule bond break while in use during a procedure could cause serious harm to the patient.

The agency noted that there have been six reported complaints from clinical cases, one injury, and no deaths associated with the use of these devices. 

Medtronic won approval for the Harmony Transcatheter Pulmonary Valve (TPV) System in March of 2021. The device offers a less invasive option to treat patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs.

The device’s approval made MD+DI’s list for 7 Moments in 2021 Destined to Change the Cardio-Device Industry Forever.

The company has had numerous recalls in the past few months.  Earlier this month, MD+DI reported that Medtronic was recalling certain In.Pact Admiral and In.Pact AV Paclitaxel-coated Percutaneous Transluminal Angioplasty balloon catheters because of manufacturing issues.

The company began 2022 with the Class I recall of the Synergy Cranial and StealthStation S7 Cranial software because of the risk of inaccuracies caused by the Biopsy Depth Gauge Cycle View.

The medtech giant ended 2021 with a Class I recall of Puritan Bennett Continuous ventilators a Class I. The issue stemmed from an error in the technology’s manufacturing assembly in which a capacitor in the ventilators is incorrectly assembled, potentially causing the devices to stop working mid-use.



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