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Manufacturer Correction – Omnipod 5 Automated Insulin Delivery System

By February 24, 2023March 6th, 2024Recalls Archive

About the Recall:

Insulet Corporation has issued an urgent medical device correction regarding the Omnipod® 5 Automated Insulin Delivery System.

Insulet Corporation has received 24 reports from Omnipod 5 users where the Omnipod 5 Controller charging port (USB-C port) and charging cable (USB cable) are melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port.

Affected product information is listed below:

Device Description: Omnipod 5 Controller
Part Number: PT-000409
UDI: 10385083000022
Serial Number: All serial numbers

If customers experience any of the issues listed above, they should disconnect the charger from the power outlet and NOT charge the Omnipod 5 Controller.

Impacted customers will receive written notification of the device correction with instructions to contact Insulet’s Customer Care team for a temporary replacement.

Customers not experiencing any of the above issues should consistently follow the actions below to reduce the risk of the Omnipod 5 Controller charging port issue:

  • Monitor your Omnipod 5 Controller while it is charging for signs of melting, deforming,discoloring, or odor. If this happens, disconnect the charger from the power outlet andcontact Insulet’s Customer Care team. DO NOT charge unattended.
  • When charging, ensure your Omnipod 5 Controller is placed on a flat, heat-resistantsurface, is not covered, and is not in an enclosed space.
  • Always inspect your Omnipod 5 Controller charging port and cable before charging forany signs of damage or discoloration. If you see signs of damage or discoloration, donot charge the device, and contact Insulet’s Customer Care team.
  • Always inspect your Omnipod 5 Controller charging port and cable for any debris beforecharging. If you see debris, use canned compressed air (electronic duster) to clean itout. Never blow air into the charging port or cable with your mouth or use hard, sharpobjects to clean it.
  • Take care when plugging and unplugging your charging cable. Do not force or bendthe end of the charging cable into the Omnipod 5 Controller charging port.
  • Only use the charging cable and power adapter that came with your Omnipod 5Controller. Contact Insulet’s Customer Care team if you need an Omnipod 5 chargingcable and power adapter.
  • Do not charge your device for longer than is needed (for example, disconnect theOmnipod 5 Controller once it reaches 100% charge).

If you have any questions or need help guiding patients, please contact Insulet’s Customer Care team at 1-800-641-2049.