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Medtronic Recalls Insulin Devices

-The Wall Street Journal

07/12/2009 - Medtronic Inc. is recalling three million insulin-infusion sets, estimating that 60,000 of them could cause improper insulin delivery and lead to serious injury or death.

The Minneapolis-based company on Friday said nearly 2% of the " Lot 8" Quick-set infusion sets in question could have a problem properly venting air pressure. The sets are used with the company's MiniMed insulin pump and include the thin plastic tubes used to deliver the drug.

Medtronic said it has mailed notifications to customers, as well as more than one million replacement sets. Patients should stop using the " Lot 8" sets, which are the only ones affected, Medtronic said.

Company spokesman Steve Sabicer said an employee identified the issue during testing.

"The recall was not triggered as a result of patient injury, and we are unaware of any known injuries associated with this field action," he said.

Most of the sets were distributed in the U.S., although a company Web site for patients notes that limited quantities of the affected products also have been distributed to 12 other countries, including Germany, the U.K., Mexico, Canada and Brazil.

Late last month, the medical-device maker came under fire from the U.S. Food and Drug Administration, which warned Medtronic about what the agency called a failure to properly report and remedy flaws in the Synchromed drug pump and the MiniMed insulin pump.

In a letter, the FDA said it took Medtronic almost two years to recall Synchromed II pumps after discovering a missing propellant in some versions. The agency also said the company didn't follow proper reporting procedures involving complaints about the insulin pump.

The bulk of the June letter related to the Synchromed pump. The company began corresponding with the FDA in January in an effort to correct the manufacturing violations.

The FDA said multiple pumps were released and implanted in patients, even though they weren't filled with a propellant needed to operate correctly. The pumps are used to release pain medicine, as well as the drug baclofen to reduce spasms.

If you or a loved one have had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation.

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