News sources report, that Medtronic Inc. issued a class 1 recall Monday of its SynchroMed II implantable drug infusion pump, making this the second such recall of the product this year.
The recalled pumps have an issue with the battery that can lead to sudden failure of the device. Class 1 recalls are reserved for the most severe of situations—those deemed probable for serious adverse consequences or death. The implantable pumps are part of the SynchroMed system that stores medication and delivers it to a specific site. A sudden failure of the device can cause a patient to experience a return of pain or symptoms or withdrawal symptoms.
In mid-July Medtronic issued an urgent warning about the pumps, stating that there had been 55 confirmed cases of the devices shutting down due to faulty batteries. It is suspected that the formation of a filmy substance within the battery caused the sudden shut down of the medical devices.
As a product defect lawyer, patient safety is something I am very aware of. I hope that everyone impacted by this faulty drug pump is receiving the proper care and support they deserve. Because of my experience as a product liability lawyer, I know that people rely on their medical devices functioning properly to maintain their health and, in some cases, sustain their lives. I encourage anyone who suspects they might be affected by the SynchroMed II recall to contact their physician right away.