Abbott recalls nearly 62K pacemakers

Abbott is recalling nearly 62,000 pacemakers after finding they have the potential to short circuit. 

The devicemaker said May 13 that a subset of its Assurity and Endurity pacemakers distributed between April 2015 and February 2019 have had problems with moisture getting inside. 

The company is recalling 61,973 of the pacemakers. The devices are designed to detect when the heart is beating too slowly and send signals to make sure it beats at the correct pace. 

If moisture gets into a pacemaker, it can cause an electrical short, which can make it stop working, make the battery drain quicker, or shorten the time between the first warning that the device's battery is low and when the battery dies.  

If the pacemaker stops working correctly, patients may experience a slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness or discomfort, the FDA said. Shorter battery life may also lead to the pacemaker being replaced sooner than expected. 

There have been 135 complaints and 135 injuries reported related to the recall, but no deaths have been reported, according to the FDA. 

Read the full news release here

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars