FDA Issues Recall for Insulet Devices for Battery, Overheating Issues that Could Cause Fire

The US Food and Drug Administration (FDA) has issued a Class I recall for the Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager over risk of battery issues that may pose a fire hazard.

Announced in a statement from the FDA on November 17, the recall, which is the most serious type of recall issued by the FDA, is indicated for 3 specific product models distributed from July 27, 2018 through August 31, 2022 and encompasses 248,288 devices in the US. In their announcement of the recall, the FDA reported Insulet has received at least 455 complaints involving battery issues for the device, including 3 fires, but there had been no reports of serious injuries or deaths.

The 3 specific models indicated in the recall are as follows:

• 18239 ASM Omnipod DASH PDM
• PT-000010: Assembly, DASH Final PDM U100, mg/dL
• PT-000011: Assembly, DASH Final PDM U100, mmol/L

Used to deliver insulin at set and variable rates to manage diabetes in people who need insulin, the Omnipod DASH Insulin Management System, includes 2 main parts: a wearable, tubeless pump that delivers insulin, called the Pod, and a remote controller called the Personal Diabetes Manager (PDM). The FDA statement describes the PDM as a “small, reusable handheld rechargeable battery-powered locked-down Android mobile device with features similar to a smartphone”. The specific reasons cited by the FDA for the recall were battery swelling, fluid leakage from the battery, and extreme overheating that may pose a fire hazard.

In a statement on November 4, Insulet detailed receiving 50 complaints related to PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire. No serious injuries or deaths have been reported as a result of this potential issue. In the statement, Insulet warned excess heat may cause minor burns or could lead to fire, but no serious injuries had been reported as a result of the issue.

“Safety is our top priority, and we have been urgently addressing this issue,” said Michael Spears Senior Vice President, Regulatory Affairs & Compliance, in the aforementioned statement from November 4. “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.”

On November 14, Insulet released a statement announcing a nationwide voluntary medical device for the Omnipod 5 Automated Insulin Delivery System, which was approved in January 2022, due to an issue with the Omnipod 5 Controller charging port and cable. In this statement, Insulet reported the receipt of 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) are melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port, which the company warned can cause minor burns or lead to fire although no serious injuries had been reported to Insulet as a result of this issue.

Insulet directed those seeking additional information, including instructions on how to mitigate risk related to any of the aforementioned issue to: www.omnipod.com/insulet-alerts.