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Medtronic recalls unused heart stents after patient dies in clinical trial

(Reuters) – Medical device maker Medtronic Plc said on Wednesday it is recalling all unused batches of its Valiant Navion thoracic stent graft system after the death of a patient in a clinical trial.

The company also informed doctors to immediately cease use of the device until further notice.

Medtronic’s shares fell 1.3% before the bell on the recall.

The voluntary recall was initiated after a global clinical trial indicated that three patients had stent fractures, with one patient death, the company said.

The stent graft is an implantable tube used to repair damage in the large artery through a small cut in the groin, without the need for a big opening in the chest.

Medtronic said it was conducting a technical investigation, including further review of follow-up clinical trial imaging and commercial complaints.

The company does not expect the recall to have a material impact on its financials.

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  • Posted on February 17, 2021