Cardiac Control Systems
This article was originally published in The Gray Sheet
Executive Summary
Issues safety alert and recall for its Maestro II pulse generators. CCS is recalling all unimplanted pulse generators and advising physicians to monitor patients with implanted devices because of the possibility for asynchronous single-chamber pacing. The firm has received three reports of asynchronous single-chamber pacing prior to or during the implant procedure due to a malfunctioning lead electrode. The firm notes that there have been no reported incidences of the malfunction in implanted pulse generators