Medtronic Diabetes receives FDA warning letter; lowers Diabetes revenue guidance

Medtronic plc

FDA warning letter dated Dec 9 for Northridge, CA facility following July 2021 inspection related to MiniMed 600 series pump and controller recalls.
No change to total company organic revenue growth or adjusted EPS guidance for Q3 or FY2022.
Diabetes organic revenue now expected high-single-digit decline Q3 FY2022 (prev. mid-single-digit); mid-single-digit for FY2022 (prev. low-single-digit).
Preliminary FY2023 total company revenue impact modeled at less than 0.5pp to ~1pp of growth; full guidance on Q4 FY2022 call.
Company applying cross-company resources and external experts to address FDA observations.

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