United States
Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Insulet received reports from Omnipod DASH users regarding PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
The Company’s investigation determined that the Omnipod DASH PDM is at increased risk of malfunction if overcharged beyond the maximum battery voltage, which could potentially lead to serious injury or death. There have been 50 complaints about this issue. No serious injuries or deaths have been reported as a result of this potential issue. As previously communicated to Omnipod DASH users, Insulet has identified an update to the Omnipod DASH PDM that will resolve this issue.
The Company expects to begin shipping updated Omnipod DASH PDMs to all current Omnipod DASH customers in the coming months. All affected Omnipod DASH consumers are being notified by email and local mail. Insulet has been providing customers with instructions to help reduce the risk of PDM battery issues.
This Medical Device Correction does not affect Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod DASH
Product recalled: Personal Diabetes Managers
Reason of the recall: Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
FDA Recall date: November 05, 2022
Source:
www.fda.gov
