Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Omnipod 5 Automated Insulin Delivery System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Omnipod 5 Automated Insulin Delivery System see related information
Date Initiated by Firm November 14, 2022
Date Posted December 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0423-2023
Recall Event ID 91127
510(K)Number K203768  
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
Product Omnipod 5 Automated Insulin Delivery System
Product catalog numbers:
PT-000409: ASM, Omnipod 5, PDM, Programmed
PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US
PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
Code Information ALL serial numbers/ controller lots are currently in scope of this recall
Recalling Firm/
Manufacturer		 Insulet Corporation
100 Nagog Park
Acton MA 01720-3440
For Additional Information Contact Insulet Customer Care
800-641-2049
Manufacturer Reason
for Recall		 The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.
FDA Determined
Cause 2		 Device Design
Action On November 14, 2022, the firm initiated their Press Release at https://investor.insulet.com/news-releases/news-release-details/insulet-issues-nationwide-voluntary-medical-device-correction and notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to monitor their Omnipod 5 Controller for the following issues: - Charging port or charging cable appears melted, deformed, or discolored - Controller experiences extreme overheating (uncomfortable to hold) or emits an odor while charging If customers experience any of the issues above, they should disconnect the charger from the power outlet and do NOT charge the Omnipod 5 Controller. Promptly contact Insulet s dedicated Customer Care team specifically trained to help you at 1-800-641-2049 to request a replacement device. If you have a compatible Android smartphone (please see omnipod.com/compatibility), you may want to switch to using the Omnipod 5 App on your smartphone. Customers were provided with additional precautions to take to continue use of the device.
Quantity in Commerce 129,086
Distribution Domestic distribution nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QFG and Original Applicant = Insulet Corporation
-
-