Product News and Recalls

FDA Warns on Leadless Heart Pacing Systems

new Medtronic pacemaker seeing issues even before releaseAfter observing what it calls “major complications related to cardiac perforation” in patients undergoing pre-market trials for Medtronic’s Micra leadless pacemaker, the FDA has reiterated its warnings to cardiac care providers over the use of leadless devices.

Pacemakers generally come in one of two varieties: either leadless or transvenous. While transvenous pacemakers have been in use for quite some time, the transition to leadless devices has caused some concern. As noted by the FDA in its recent communication, “Information from real-world usage suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers.”

Medtronic is no stranger to recalls. The company has had a line of heart pumps pulled from the market, as well as its Rashkind balloon septostomy heart catheter. In addition, 322,000 of its MiniMed insulin pumps were the subject of a Class I recall after it was discovered that a faulty component in the pump was causing it to potentially over- and under-deliver insulin to diabetes patients. A Class I recall is the FDA’s most aggressive recall action and is reserved for situations were continued use of the recalled drug or device could cause serious injury or death. Indeed, at least one fatality had been blamed on the MiniMed defect, as well as over 2,100 injuries.

Sadly, these are just a few of the recalls issued over Medtronic’s failures. And as the company works to bring a new device to market that is already causing significant and serious complications for those who are using it, one must wonder whether the Micra pacemaker will eventually join Medtronic’s long list of recalled products as well.