FDA Provides Further Warning About Medtronic Infusion Pump Recall

The U.S. Food & Drug Administration and Medtronic Neuromodulation, the Minnesota-based medical device giant, issued a Class I recall of the company’s SynchroMed II Implantable and SynchroMed EL Implantable Infusion pumps due to motor stalling and drug dispensing issues which could result in serious adverse health risks or death.

Medtronic Drug Infusion Pump Recall & Follow Up

In November, the FDA issued a Class I recall on the Medtronic SynchroMed II Implantable Drug Infusion Pump and the SynchroMed EL Implantable Drug Infusion Pump, which are used to administer prescription drugs or fluids to a specific site inside a patient’s body.

The Class I recall, the FDA’s most serious classification of recall, was based on a 2.4% failure rate of the pumps when used to dispense drugs approved by the company and the FDA and a 7.0% failure rate of the pumps when used to dispense similar (but unapproved) drugs. In addition, the FDA says that the use of unapproved drugs in these medical devices can lead to intermittent or permanent pump motor stall. If that occurs, the cessation of drug infusion can cause serious adverse health consequences, including death. Medtronic says that it is also investigating issues of motor gear corrosion, which may have contributed to the known defects.

The FDA followed up on December 21, 2012 with another notice warning healthcare professionals not to use compounded drugs, concentrations or formulations not approved by the FDA for use with the SynchroMed infusion pump.

Medtronic Recall Details

The following infusion pump models, manufactured from May 1998 through November 2012, were part of the recent Medtronic recall and FDA follow up:

  • SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.)
  • SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18

If you’ve been injured by a defective medical device, it’s important to understand that you may be entitled to compensation for your injuries including lost wages, medical bills and pain and suffering. The Driscoll Firm, LLC, is here to help. We have recovered over $170 million for our clients in the past three years alone and will do our very best to help you and your loved ones.

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