The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level.
Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system.
The Omnipod Dash includes a Personal Diabetes Manager (PDM) — a locked-down Android mobile device with features similar to a smartphone that controls the Pod delivering insulin. The FDA says Insulet has received 455 complaints involving the battery issues, including three fires. There have been no reports of injuries or deaths.
Reported problems include battery swelling, fluid leakage from the battery, and overheating.
How Insulet is responding to the Omnipod Dash battery problems
Insulet has said that it identified an update to the PDM that addresses the issue. The company plans to begin shipping updated PDMs to customers in the coming months. Users will automatically receive them when they’re available.
In the meantime, Insulet says Omnipod Dash users should call customer care at 1-800-641-2049 and request a temporary replacement device if they notice any of the following problems with the PDM:
- The back cover bulges or cannot close. Insulet says not to apply pressure to the back cover if it is deformed in any way. The PDM’s gel skin will need to be removed to observe these issues, but do not remove the back cover.
- Extreme overheating or an odor while charging, during use, or in storage.
- The device turns off immediately after removal from the charger or fails to turn on within 45 minutes of being connected to the charger.
- Battery loses charge very quickly (faster than usual) or takes more than 1.5 hours to reach 80% charge.
The FDA has more information about the recall on its website.
Also recently, Insulet announced a medical device correction for its Omnipod 5 automated insulin delivery system involving the system controller’s charging port and cable.