Dive Brief:
- The Food and Drug Administration said Monday it has issued a Class I recall notice regarding Medtronic’s removal of heart vent catheters.
- Medtronic previously asked customers to quarantine lots of its DLP Left Heart Vent Catheters in response to an issue linked to three serious injuries. The FDA published an early alert about the recall in August.
- The agency updated its notice this week to inform the public that it has classified the issue as a Class I recall.
Dive Insight:
The recalled devices are indicated for venting the left heart for up to six hours during cardiopulmonary bypass procedures. According to the Canadian government, there has been an increase in complaints about the devices since March 2024. The complaints described catheters resisting shape retention when being bent.
By July 28, Medtronic had received 41 complaints about shape retention. The complaints included three reported perforation injuries. While no patients had died, Medtronic said fatalities could occur if a device caused complicated, unnoticed or untreated perforation of critical heart tissue.
Other complaints described delayed or prolonged procedures that had no impact on the patients. The company said the identification that the device is faulty before the procedure starts could cause delays while another cannula is located.
The FDA published an early alert about the recall shortly after Medtronic wrote to customers. The agency uses the early alert program to support the timely dissemination of information on events that are likely to be the most serious type of recalls. Before implementing the program, the FDA typically waited until formally assigning a recall to a risk class before publishing information on a company’s actions.
Medtronic had corrected the issue for newly manufactured lots by the time it wrote to customers, but warned that it would have limited product availability for a few months. The company offered credit to customers who were unable to source a suitable replacement for a recalled device.
