The thoracic stent graft system is intended to repair lesions, such as aneurysms, in the large artery in the chest.
Medtronic said seven out of 87 patients in the clinical trial had stent ring enlargement beyond the device’s design specifications. The company said it has informed physicians to immediately stop using the device until further notice and said patients with the device should consult with their physicians.
Medtronic said it is conducting an investigation and further reviewing the clinical trial information.
“There is nothing more important than the safety and well-being of patients,” said Nina Goodheart, senior vice president and president of Medtronic’s structural heart and aortic division. “We treat matters of product safety with the highest priority and urgency. Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies.”
Read the full news release here.
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