Insulet Issues Medical Device Correction For Omnipod 5 Controller Due To Faulty Charging

Insulet Corporation (NASDAQ:PODD) announced a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System because of an issue with…
  • Insulet Corporation (NASDAQ:PODD) announced a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. 
  • Insulet has received 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) is melting, deforming or discoloring due to heat generated by a poor connection between the cable and the port. 
  • Related: Insulet Shares Jump After Q3 Earnings Surpass Expectations, Improved Annual Guidance.
  • The excess heat may cause minor burns if those areas of the Controller are touched or could lead to a fire. No serious injuries have been reported to Insulet as a result of this issue.
  • Omnipod 5 users are being notified by email with instructions on detecting and reducing the risk of an issue with the charging port or cable. 
  • This does not impact the Omnipod 5 Pod, the Omnipod DASH Insulin Management System, the Omnipod Insulin Management System, or compatible Android smartphone devices with the Omnipod 5 App installed. 
  • These actions are taken voluntarily with the knowledge of the FDA.
  • Price Action: PODD shares are up 2.82% at $298.27 on the last check Tuesday.
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