Diabetes device recalled due to risk of fire
The FDA recently announced a class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard.
Insulet Corporation issued a class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard, the FDA announced Nov. 16.
There have been 455 related complaints, including reports of three fires. No injuries or deaths have been reported. The recall includes 248,288 devices distributed from July 27, 2018, to Aug. 31, 2022.
The company on Nov. 14 also issued a separate medical device correction for the Omnipod 5 Automated Insulin Delivery System due to an issue with the controller's charging port and cable. There have been 24 reports of the charging port or cable melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port. No related serious injuries have been reported.