Medtronic got a warning letter from the FDA concerning its procedures for dealing with problems with two of its products. The letter cited a Medtronic failure to report on problems with its SynchroMed II drug-infusion pump and an insulin pump made by its MiniMed unit. The FDA said Medtronic took nearly two years to recall the SynchroMed pump, which was lacking a propellant in some of the devices. As for the MiniMed pump, the agency said the company failed to adhere to reporting procedures for dealing with complaints about its insulin pumps.(Click here for more – a subscription may be required)
“FDA Warns Medtronic On Synchromed, MiniMed Pumps” – Wall Street Journal ( (6/24/09)
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