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Quick-set® infusion sets are sets of flexible, plastic tubing, thinner than spaghetti, that diabetics use with the Medtronic MiniMed Paradigm insulin drug pumps. The sets, which are changed every two or three days, deliver insulin to the diabetic patient from drug pumps worn on a belt or in a pocket.

Medtronic recalled the infusion sets in July 2009 after discovering that about two percent of them result in complications that can prevent the insulin pump from venting air pressure properly. As a result, the pump could deliver either too much or too little insulin, causing injury or death. 

About 60,000 sets out of an estimated three million might be affected. The Food and Drug Administration (FDA) announced the recall in conjunction with Medtronic.

The sets recalled are from Lot 8 and are marked with reference numbers

• MMT-396
• MMT-397
• MMT-398
• MMT-399

Medtronic is replacing the sets with properly functioning ones at no charge.

Medtronic Infuse Bone Graft

The Infuse Bone Graft is a biological substance approved by the FDA to be used in conjunction with Medtronic’s LT Cage Device to treat degenerative disc disease in the lower back. The substance and cage device are surgically implanted.

Use of the biological substance, a naturally occurring protein, precludes the need to take bone from a patient’s hip and transplant it to the lower spine. The protein, which regulates and promotes bone growth, allows two vertebrae to fuse and stabilize the spine.

Off-Label Use. While the Infuse Bone Graft is approved by the FDA to be used in the lower back, Medtronic has been promoting the medical device for off-label use (not FDA-approved) to stabilize the cervical spine or upper spine and neck. Some patients who have had surgery to implant this device in the cervical spine are now facing serious complications.

The device may be linked to problems including:

• unwanted bone growth
• swelling of bone tissue in the neck
• compression of  the airway that compromises breathing, swallowing, and speaking

Medtronic Infusion Systems and Devices

In addition to infusion systems to treat diabetes and spinal problems, Medtronic sells other infusion systems to treat:

• Chronic pain in the back and leg
• Complex regional pain syndrome
• Painful neuropathy
• Brain injury
• Severe spasticity linked to cerebral palsy and multiple sclerosis
• Spinal cord injury
• Stroke

If you believe you have been harmed by a recalled infusion set, contact our medtronic lawyer today.

"Medtronic agrees to settle 2,682 product liability lawsuits for $95.6 million"

Medtronic, the world’s largest maker of implantable cardioverter defibrillators (ICDs), has agreed to settle 2,682 product liability lawsuits for $95.6 million.

Marquis ICDs

The lawsuits were filed in connection ...

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"Defective Heart Catheter Made by Medtronic Lawsuit Goes to High Court"

The Supreme Court heard arguments in a controversial case involving a defective heart catheter made by Medtronic on Tuesday. At issue is whether or not the manufacturer can be held liable under state law for the plaintiff’s injuries since the dev...

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"Faulty Electrical Lead in Heart Defibrillators"

A vital wire in certain implanted heart devices may falter and cause serious injury, possibly even death, according to an announcement made by the Food and Drug Administration on Monday. The defect has prompted the maker of the part to issue a voluntar...

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