Medtronic Has Another Class I Recall

The FDA on Wednesday designated Medtronic's voluntary recall of a cerebrospinal fluid draining and monitoring device as Class I.

Officials at the agency think that the recalled Medtronic Duet External Drainage and Monitoring System could cause serious injury or death because the patient line tubing may separate from the patient line connectors during frequent handling. Such a device failure could result in air within the skull (pneumocephalus), infection such as meningitis, ventriculitis, encephalitis, and over and under drainage of the cerebrospinal fluid, according to the FDA. This is Medtronic's ninth Class I-level recall since the start of 2012. Only Johnson & Johnson and CareFusion have had more serious recalls.Medtronic says there have been no permanent serious injuries or deaths connected with the Duet recall.Between September 2013 and April 2014, Medtronic received reports of 35 events, but there have been no additional reports since the company implemented additional controls to address the issue, according to a statement provided by Medtronic spokeswoman Cindy Resman.The company's statement also said: "Disconnections of the patient line, if they occur, are more likely to occur during handling of the system by a healthcare professional. The event would likely be noticed immediately and could be addressed without exposing the patient to significant risk."The affected Duet products were made from March 15, 2013 through February 28, 2014, and distributed from April 10, 2013 through May 19, 2014. Affected lot numbers are included with the recall announcement.The Medtronic Duet External Drainage and Monitoring System externally drains and monitors cerebrospinal fluid and monitors intracranial pressure. It can be inserted either through the skull or spine.

The device is supposed to be used only when trained personnel are around to supervise monitoring and drainage around the clock.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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