Medtronic Recalls Cardiac Catheters Over Safety Concerns

The US Food and Drug Administration (FDA) has issued an early alert following Medtronic’s recall of certain cardiac catheters after three reports of serious injuries.

On Aug. 6, Medtronic notified customers to quarantine 232 lots of its DLP Left Heart Vent Catheters, used during cardiopulmonary bypass procedures. The devices, designed to be malleable, were reported to resist shape retention when bent, potentially delaying surgeries or causing cuts to heart tissue.

Although no deaths have been reported, the FDA warned that damage to heart tissue could be fatal if unnoticed or untreated. The agency has included the recall in its early alert pilot program for potentially high-risk device issues.

Medtronic said the defect has been corrected in newly manufactured devices, but supply will be limited in the coming months. Customers unable to obtain stock are advised to contact sales representatives for alternatives, with credits issued if replacements are unavailable.

23-08-2025