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FDADecember 18, 2018device

Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

What to do

FDA enforcement status: Terminated

Brands named

insulet

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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