Insulet is recalling 7 million insulin patch pumps due to a manufacturing issue where devices may have a small tear in the tubing just above the skin.
The problem can cause insulin to leak outside of the body, with the potential for people to not receive enough medication. For people with diabetes, this can lead to serious complications associated with high blood sugar, such as diabetic ketoacidosis, a medical emergency caused by a severe lack of insulin.
Insulet said in a Tuesday notice that it has received 24 reports of serious adverse events, including hospitalization and diabetic ketoacidosis. The company has not reported any deaths related to the recall.
The correction applies to certain lots of Insulet’s Omnipod 5, Omnipod DASH and older Omnipod Insulin Management System pods. In total, the devices represent 8.5% of the company’s global production. Insulet said more than half of the affected devices may have been consumed or expired. People using one of the affected pods may notice wetness on their skin or the smell of insulin, but the issue may be difficult to detect, the company said.
Insulet expects to incur up to $50 million in costs this year related to the action, the company said in a securities filing. Most of the expected expenses are related to pod replacement and customer support, Leerink Partners analyst Mike Kratky wrote in a research note. Insulet does not expect the correction to affect its 2026 forecast, new customer starts or attrition.
Two recalls related to tears
In March, Insulet recalled some of its Omnipod 5 devices for a different tubing problem. A tear in the internal tubing could cause insulin to leak inside of the pod, the company said then. The event, which was separate from the latest correction, affected about 1.5% of Insulet’s global Omnipod 5 production and was expected to cost the company $40 million this year.
The latest recall involves a different tear location and different product lots, an Insulet spokesperson wrote in an email.
The two problems stem from different manufacturing processes at Insulet’s Acton, Massachusetts, facility. Following the March recall, Insulet put in place stronger quality controls to detect cannula tears, but the devices from the latest action were manufactured before those controls were implemented, RBC Capital Markets analyst Shagun Singh wrote in a research note.
Leerink Partners’ Kratky said Insulet reported process enhancements due to the corrections have been implemented network-wide, not just in the Acton facility.
