Medtronic Neuromodulation of Minneapolis Minnesota has announced that it is recalling several of its implantable infusion pumps after receiving reports of inflammatory mass formations near the tips of the devices. The recall has been categorized as Class 1, the most serious class of recalls for dangerous or defective products that predictably could cause serious health problems or death.

Recall details

The following Medtronic Neuromodulation Implantable Infusion Pumps, which administer drugs to a specific site in the body to treat pain, spasicity (continuous muscle contraction) and cancer are subject to the company’s latest recall:

• SynchroMed EL Implantable Infusion Pump, Models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, 8627L-18
• SynchroMed II Implantable Infusion Pump, Models 8637-20, 8637-40,
• IsoMed Implantable Infusion Pump, Models 8472-20, 8472-35, 8472-60.

The implantable components of the infusion systems listed above include the pump, a side catheter access port, catheters, and/or catheter accessories. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories.

Medtronic reports that the most frequently reported symptoms of inflammatory mass are decreased therapeutic response, pain, and neurological deficit/dysfunction. Serious reported symptoms include paralysis and other neurological impairments.

Warnings updated

Medtronic has stated that it has updated the warnings on its pumps and the risk of inflammatory mass formation has been included in the labeling for its implantable drug infusion systems as either a Warning or Precaution, since 2001 and in the prescribing information for Infumorph (preservative-free morphine sulfate for microinfusion pumps registered to Baxter Healthcare) since 2003. Medtronic also recently received FDA approval for an update to the device labeling to include these new data.

Dear Doctor letters sent

According to the U.S. Food and Drug Administration (FDA), Medtronic sent out “Dear Doctor” letters describing the problem with the pumps, patient risks, patient management, recommendations and next steps. To view the letter, go to wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1205958103681/

Additional information

Patients with questions should talk to their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT.