Highest FDA recall issued for certain catheters, heart pump controllers

The Food and Drug Administration has identified a Class I recall of reprocessed electrophysiology and ultrasound catheters by Medline Industries due to specific lots potentially containing small residual particles. The FDA said that all affected products should be destroyed after recall response actions are complete. The agency also identified a Class I recall of all Automated Impella Controllers by Abiomed () due to the potential of an internal software error when a patient experiences a period longer than 80 minutes with no residual pulsatility. The Abiomed recall involves updating use instructions and does not involve removing them from where they are used or sold. 
 
The FDA also issued an early alert for catheter introducer kits by Abiomed and Oscor due to a potential for introducer sheath leakage.