FDA warns of Omnipod cannula tear that can quietly cut off insulin — sometimes with no alarm

The FDA’s device center has issued an Early Alert flagging a “potentially high-risk device issue” in Insulet’s Omnipod insulin pumps: a small tear can form in the cannula tubing just above the skin, letting insulin leak out instead of dosing the patient. The agency cautions that this can happen without setting off any alarm.

The alert follows a voluntary Medical Device Correction that Insulet announced on May 26 for specific lots of three product families — the Omnipod 5 Automated Insulin Delivery System, Omnipod DASH, and the original Omnipod (Eros) system — in the U.S. and affected international markets. By the company’s own count, roughly 7 million Pods fall within the scope of the action, about 60% of which have already been consumed or expired. That represents about 8.5% of 2025 global Pod production.

A leak you may not feel

The hazard here is under-delivery, not overdose. According to Insulet’s release, the tear sits between the Pod and the point where the cannula enters the body, so insulin can escape outside the Pod. Patients might notice wetness, sticky adhesive, or the smell of insulin — but the FDA is blunt that detection can fail: “this issue may happen without triggering any alert, meaning you could receive less insulin than needed without realizing it. Do not rely only on Pod alerts to know if something is wrong.”

“In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA) … and can be life-threatening if not treated.” — FDA Early Alert

As of May 20, Insulet had logged 24 serious injuries associated with the issue and no deaths, the FDA reports; the company’s release characterizes the same 24 as serious adverse events tied to high blood glucose, including hospitalization and DKA. Both the FDA and Insulet confirm no deaths.

What the FDA tells affected patients to do

Critically, the agency does not tell patients to stop insulin therapy — the opposite. The Early Alert’s core protective instruction is to swap the suspect Pod for a working one so dosing continues: “If you are currently using a Pod from an affected lot, immediately change your Pod to resume insulin delivery.” If changing the Pod then leaves you short, the FDA says to “talk to your healthcare provider about other methods of insulin delivery.” The action, in other words, is to replace — not abandon — insulin delivery, either with an unaffected Pod or, if none is available, an alternate method arranged with your clinician. No reader should infer they should simply stop using their pump without a substitute in place.

The FDA stresses that this is a separate, new issue from Insulet’s March 12 removal of certain Omnipod 5 Pods — itself a Class I recall, the agency’s most serious category, covering 49 lots and 1,240,115 units, in which a manufacturing defect caused an internal cannula tear that leaked insulin into the Pod. Patients can check whether their lot is affected using Insulet’s lot-lookup tool and request free replacements; the company says it has sufficient supply and does not anticipate a shortage. This is reporting, not medical advice — patients with affected Pods should follow the FDA’s instruction to change the Pod immediately and continue insulin delivery, and should contact Insulet and their clinician with questions.