FDA has requested to meet with Medtronic officials Sept. 7 to discuss ongoing concerns with actions the firm is taking to mitigate risks tied to its SynchroMed II drug infusion pump, according to a warning letter
sent by the agency last month.
FDA To Meet With Medtronic On Drug Pump Risks; Warning Letter Sent
The agency posted a warning letter to Medtronic Aug. 21 citing the firm for multiple quality system deviations, including lapses in its efforts to address a failure risk for the SynchroMed II drug infusion pump.