Dive Brief:
- Insulet is recalling a portion of its Omnipod 5 insulin patch pumps over a problem that could lead to under-delivery of insulin.
- Devices from specific lots may have a small tear in the internal tubing, which can cause insulin to leak inside the pod instead of being delivered into the body, Insulet said in a Thursday recall announcement.
- Insulet has reported 18 serious adverse events associated with high blood glucose levels, including hospitalization and diabetic ketoacidosis. The company has not received reports of deaths related to the problem.
Dive Insight:
Insulet expects to incur up to $40 million of costs this year associated with the recall, the company said in a financial filing Thursday. The company is not changing its expectations for revenue growth of 20% to 22% in 2026 on a constant currency basis.
Insulet said it is sending affected customers free replacement pods. After an investigation, the company has implemented updates to its manufacturing processes and quality controls.
The company did not share a total number of affected devices, when asked. Insulet estimates the correction represents about 1.5% of its annual global Omnipod 5 production.
Insulet said it does not expect the recall to disrupt customer shipments, product availability or new patient starts for its Omnipod 5 devices.
Mike Kratky, an analyst with Leerink Partners, said the news represents “an unwelcome development” for Insulet, but he does not expect a significant shift in market share or commercial patterns as a result.
The recall follows other recent high-profile safety events across the diabetes tech industry, including warning letters to insulin infusion set supplier Unomedical over leaking infusion sets, glucose sensor maker Abbott over accuracy concerns and insulin pump maker Beta Bionics following reports of hyperglycemia and hypoglycemia.
