Insulet has announced a recall for select lots of Omnipod 5 Insulin Pumps after receiving 18 reports of serious injuries, including hospitalizations and cases of diabetic ketoacidosis (DKA). No deaths were reported.
The recall involves a problem with internal tubing inside the device. If the tubing tears, insulin can leak inside the device instead of being delivered to the patient’s body. This can lead to under-delivery of insulin.
For people with diabetes who rely on continuous insulin delivery, even a brief disruption can trigger dangerously high blood glucose levels. According to the recall announcement posted by the FDA:
If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment.
Insulet says it has already investigated the root cause and updated its manufacturing processes and quality controls to prevent the problem from recurring.
Customers are being sent free replacement pods, and the company does not expect the recall to disrupt shipments or patient access to the device.
Patients who use Omnipod 5 should check whether their pods are from an affected lot using information provided by Insulet. You can also contact the company directly if you have questions about the free replacement.
People who experienced high blood glucose events or hospitalizations they believe may be related to their device may have legal options worth exploring.
Source: Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.