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  4. Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022
  1.  Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
Company Name:
Insulet Corporation
Brand Name:
Brand Name(s)
Insulet Corporation Omnipod DASH
Product Description:
Product Description
Personal Diabetes Managers

Company Announcement

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.

“Safety is our top priority, and we have been urgently addressing this issue,” said Michael Spears Senior Vice President, Regulatory Affairs & Compliance. “We are committed to helping our customers navigate the replacement process and address any concerns they have. We are confident that a software update will resolve this issue.”

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. Users who experience any issues with their battery should contact Insulet’s dedicated Customer Care team at 1-800-641-2049, which is available in the U.S. 24 hours a day, 7 days a week. Country-specific Customer Care phone numbers are available on .

This Medical Device Correction does not affect Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System. Additional information, including instructions to customers to mitigate risk, can be found on the Company’s website at .


Company Contact Information

Consumers:
Customer Care
1-800-641-2049
awiczek@insulet.com
Media:
Angela Geryak Wiczek
(978) 932-0611
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