The Recall Desk

FDA (Devices) recall action 71651

Insulet Corporation recalled 2 products on 2015-09-16

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-09-16
Critical
0
Units
—

Why these products were recalled

OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • SevereFDA (Devices)··2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Distribution
    0 states