Agency classClass IOur severity:Severe FDA (Devices)·Z-0154-2023·Announced 2022-11-23

Omnipod Dash PDM Insulin Pump Remote Recalled for Battery Fire Hazard

Insulet Corporation is recalling the Omnipod Dash PDM remote controller for insulin pumps due to battery defects causing overheating, swelling, and fire hazard. A fire incident has been reported.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I, the highest severity classification for medical devices. Additionally, the source documents a complaint of actual fire occurrence resulting from thermal energy generated by the defective battery, constituting reported property damage and significant potential for injury.

Plain-English summary

Insulet Corporation is recalling the Omnipod Dash PDM (Personal Diabetes Manager), a remote controller used with insulin pump systems. Approximately 248,288 units have been distributed in the United States, and 167,802 units have been distributed outside the US, including in Canada, Europe, Australia, and the Middle East. All serial numbers and lots of the affected part numbers are included in this recall.

The Dash PDM remote controllers can develop battery defects, including battery swelling, fluid leakage from the battery, and extreme overheating. These defects pose a fire hazard. The manufacturer has received a complaint alleging that a fire occurred as a result of thermal energy from a Dash PDM.

This recall affects users of the Omnipod Dash PDM remote controller devices. The affected part numbers are 18239, PT-000010, PT-000011, and PT-000030.

The recalled product

Product: 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump…
Manufacturer: Insulet Corporation
Category: Medical Device — Insulin Pump / Remote Controller
Hazard: fire
battery-swelling
overheating
battery-leakage

Distribution

Distributed nationwide across the United States.

Same manufacturer · Insulet Corporation

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