Medtronic Synchromed Infusion Pump Recall by FDA

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As of April 2015, dozens of recalls have been issued over the Medtronic Synchromed infusion pump system. Over 30 of these recalls have been deemed Class I recalls by the U.S. Food and Drug Administration (FDA). The FDA reached an agreement with Medtronic Inc. over flaws in its Synchromed drug infusion pump, a device that has been linked to serious injuries and deaths in recent years.

Medtronic Inc.’s Synchromed pump devices are surgically implantable devices meant to deliver medication to an area near a patient’s spinal cord. The Synchromed II drug pump system is used to treat patients who have been diagnosed with cancer, severe muscle spasms, chronic pain, and other serious disorders and who do not respond to oral medications or who have suffered severe side effects associated with oral medications.

In 2012, the FDA issued a warning letter to Medtronic that cited the company for failing to correct problems with the devices, including their potential to stall due to motor corrosion and to fail to deliver medication.

The company won’t be allowed to resume widely distributing the Synchromed II pump system until it gets permission from the FDA. Medtronic said the Synchromed system has been used in more than 230,000 patients since it was introduced more than 25 years ago.

If you or a loved one has suffered complications as a result of a Synchromed pump implant, you may be entitled to legal compensation from the manufacturers of these defective products. The lawyers of the firm Taylor Martino are ready to evaluate your claim and assist you in seeking compensation for your pain, suffering, and other physical injuries, the cost of restorative surgery as well as other financial difficulties, resulting from injuries caused by these defective products.