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Federal officials have announced a recall for a specific model of heart catheter made by Medtronic PLC that regulators said is responsible for one death and two injuries.

The action Tuesday involves 142 Rashkind balloon septostomy catheters that were distributed in the United States from May 2018 to August 2020.

“Quality issues … may lead to the device breaking, separating or failing during use,” according to the U.S. Food and Drug Administration (FDA).

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