Medical device giant Medtronic (NYSE:MDT) announced this week that the FDA had put its highest-risk label on the field safety notices regarding issues with the company’s SynchroMed II and SynchroMed El implantable pain pumps.
The FDA recently labeled 3 of the 4 SynchroMed issues Class I recalls, a designation reserved for situations "in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death."
The 4th warning was listed as an update to a 2011 action, which the FDA had previously labeled a Class I recall, according to the Medtronic statement.
Overseas healthcare agencies this week posted updates on the SynchroMed pumps, warning that they may be prone to electrical shorts, bolus priming issues and other concerns that could put patients at risk.
The new warning came on the heels of a March 2013 U.K. warning as well as a December 2012 FDA Class I recall for the SynchroMed line, which is slowly fading from use.
"The SynchroMed EL has been discontinued and based on Medtronic data, at least 90% of the remaining actively implanted SynchroMed EL pumps are near expected end of service," according to China healthcare regulators.
Medtronic recommended against prophylactic or preventative removal of the SynchroMed implants, but recommended that providers take extra care with patients, increase monitoring and prime all new pumps prior to implant or connection to a catheter to reduce the risk of overdose.
The SynchroMed line has been the subject of a few field actions in recent years. In July 2011 Medtronic warned that some of its SynchroMed II pumps may have defective batteries that could result in sudden device failure. By the time the warning was made public more than 50 confirmed battery defect failures had occurred. The battery issue spurred an FDA Class I recall, a label reserved for medical device recalls considered of the highest potential risk to patients.