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Dec 24, 2025 12:10 PM

FDA Flags Medtronic Heart Catheter Recall As Most Serious Safety Risk

The U.S. Food and Drug Administration (FDA) said it is aware that Medtronic Plc (NYSE:MDT) has notified customers to remove certain Left Heart Vent Catheters from use and sale, citing safety concerns.

The catheter is used to vent the left heart during cardiopulmonary bypass procedures lasting up to six hours.

The agency classified the action as a Class I recall, its most serious category, indicating continued use could result in serious injury or death.

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