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FDA Issues Recall on Medtronic Implantable Pain Pumps

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Silver Spring, MDSix months after Medtronic issued a voluntary recall on certain potentially defective catheters, the Federal Drug Administration has announced an update on a previous recall on two of Medtronic's implantable drug pumps.

The FDA on March 14 announced a recall on Medtronic's SynchroMed II and SynchroMed EL implantable drug infusion pumps used to treat primary or metastatic cancer, chronic pain and severe plasticity.

An application software problem on the infusion pumps can cause unintended delivery of drugs during a priming bolus procedure, a process used to quickly deliver a large dose of medication from the device to the patient's spine.

According to the FDA's SynchroMed II and SynchroMed EL recall information, the pain pumps could unintentionally release drugs at a high infusion rate, followed by a slower than intended rate during the priming bolus procedure. The defect could potentially cause drug overdosing or underdosing, leading to serious injuries, coma or death.

In October 2016, Medtronic issued an update to its 2013 recall of certain models of SynchroMed II and SynchroMed EL, advising health care providers to continue using the current model 8870 software card until a Medtronic representative exchanged the card with a new version.

The recent pain pump recall follows Medtronic's voluntary October 2016 recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters.

Medtronic recalled those products because the polytetrafluoroethylene (PTFE) coating on parts of the devices could potentially separate from the delivery wire or stylets, causing PTFE particulate to enter the blood stream of the patient and potentially cause a stroke or death.

Additional catheter products manufactured by other medical device companies have also been recalled over the past two years due to their potential to cause life-threatening injuries.

In April 2016, the FDA issued a Class 1 recall of the Fetch 2 Aspiration Catheter, manufactured by Boston Scientific Corp. The recall stemmed from reports of breakage along various points of the device before or during procedures. Such breakage could cause pieces of the catheter to block blood supply to the heart or blood vessels, resulting in the need for additional medical procedures, patient injury or death.

In October 2015, Cook Medical also recalled 4.1 million Beacon Tip Angiographic Catheters. The devices were found to experience tip splitting or separation, which could lead to blocked blood flow to organs. Cook expanded its original recall later to include several additional catheter devices, including the Shuttle-Select Slip-Cath and Beacon Tip Catheter.

Medtronic's pain pump recall is the latest in a long list of various recalls by medical device manufacturers. The recall update affects distribution dates from September 2013 to October 3, 2016 for SynchroMed II and SynchroMed EL.


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