Medtronic Recalls SynchroMed Infusion Pump

Medtronic Inc., the manufacturer of the drug infusion device known as the Medtronic SynchroMed Implantable Infusion System, has recalled the medical product after reports surfaced that it has lead to at least 14 deaths.  The recalls specifically relate to the following models:

• Medtronic SyncroMed II, models 8637-40 and 8637-20
• Medtronic SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8627-10, 8627L-10, 8627-18 and 8627L-18

The recall was ultimately prompted by the United States Food and Drug Administration (FDA) issuing a class I recall of the devices, which indicates potential fatal consequences.  Medtronic’s Synchromed II and Synchromed EL models were designed to administer precise levels of drugs or fluids into an individual’s blood stream.  The battery powered device pumps the drug through a reservoir valve and into the pump reservoir.  Once there, pressurized gas pushes the drug into the SynchroMed tubing, where a pre-programmed dose is then dosed out through the catheter. Approved drugs have included:

• Infumorp
• Lioresal
• Prialt
• Floxuridine
• Methotrexate
• Glablofen

Who Is Medtronic Incorporated?

Medtronic, Inc., headquartered in Minneapolis, MN, in the world’s largest manufacturer of heart devices.  The company has acknowledged that over 200,000 SynchroMed devices have been implanted worldwide.  While 14 deaths have already been linked to this product, the vast majority go unreported, or are wrongly categorized.  In other words, the SynchroMed models are probably related to many more deaths.

What Should I Do If I Been Implanted With a Medtronic SynchroMed Pump?

Unfortunately, Medtronic suggests that patients should not have the SynchroMed device removed if they have already been implanted.  Instead, patients are urged to contact their doctors and notify them of the recalls associated with the device.  Furthermore, individuals should monitor the device and seek immediate care if a complication should arise.  Also, only approved drugs mentioned above should be administered.

Contact a Medtronic SynchroMed Attorney

If you or a loved one has had the Medtronic SynchroMed Infusion Pump installed and are experiencing complications, do not hesitate to contact one of our attorney. We offer free case evaluations to all prospective clients of the device.