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Medtronic Inc. (MDT)’s SynchroMed infusion pumps were found to have four flaws that have led to 14 patient deaths, spurring U.S. regulators to issue their most serious recall on the implantable device used to deliver pain and other medications.

Medtronic, the world’s largest heart device maker, notified customers in early June about the flaws that may interfere with the safe and reliable delivery of medications using the SynchroMed Implantable Infusion System, the Minneapolis-based company said in a statement. Each flaw specified in the notifications was deemed a Class 1 recall by the U.S. Food and Drug Administration, denoting potential life-threatening issues.

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