Updated 7/2/2014 at 3:30 p.m. EST with comments from Medtronic.
The device, part of Medtronic’s Neurosurgery division, helps continuously drain cerebrospinal fluid and monitor intracranial pressure under supervision from a trained clinician.
Medtronic pulled several lots of the devices last month over concerns that the patient line tubing may become disconnected. That could allow air to collect inside the skull, may result in infection or could cause over- or under-drainage, according to the FDA notice.
"Between September 2013 and April 2014, Medtronic received 35 events," Medtronic spokeswoman Cindy Resman told MassDevice.com today. "There have been no reports of patient deaths or permanent serious injuries as a result of this issue. Since Medtronic implemented additional controls to address the issue there have been no reports of this from customers."
The federal watchdog agency gave the recall its highest-risk Class I label, reserved for issues that the FDA believes "may contribute to serious adverse health consequences, including death."
"Disconnections of the patient line, if they occur, are more likely to occur during handling of the system by a healthcare professional," Resman said. "The event would likely be noticed immediately and could be addressed without exposing the patient to significant risk."
Medtronic last month issued an Urgent Medical Device Recall letter asking customers to stop using all affected lots of the Duet system and to take extra care with any systems already in use.
The recalled devices were manufactured from March 15, 2013, through February 28, 2014, and distributed from April 10, 2013, through May 19, 2014, the FDA said.