An FDA-recorded root-cause determination. The FDA lists 86 recalls with this root cause since 2025, 14 of them Class I (most serious). Most recent report: Jul 8, 2026.
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
Due to unsealed portions of pouches.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the f…
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and…
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus deliv…
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.