FDA issues Class I recall for Medtronic heart vent catheters

The FDA has classified Medtronic’s DLP Left Heart Vent Catheters recall as Class I, following reports of serious injuries. The devices, used to vent the left heart for up to six hours during cardiopulmonary bypass procedures, were previously quarantined by Medtronic after three patients experienced perforation injuries.

Since March 2024, the company received 41 complaints, including issues with catheters resisting shape retention. While no deaths occurred, Medtronic noted that undetected perforations could potentially be fatal. Other complaints involved delayed procedures without patient harm.

The FDA initially issued an early alert in August to promptly inform the public. Medtronic has corrected the issue in new lots, though limited availability may persist for several months. The company also offered credit to customers unable to source replacements during the recall period.

28-12-2025