Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-00
Summary
The FDA issued a Class II for Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409 by Insulet Corporation. Reason: 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 d.
Details
Source
Device Recall
External ID
Z-0423-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: ALL serial numbers/ controller lots are currently in scope of this recall
Quantity Affected: 129,086
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.
Distribution
Domestic distribution nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-14
Company
Acton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Insulet Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Insulet Corporation have FDA actions?
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0423-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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