An FDA Recall Record Says a Defect in Version 7.9 of an Insulin Pump's Software Will Cause It to Incorrectly Interpolate Glucose Trends Under Conditions It Describes

The U.S. Food and Drug Administration keeps a public database of medical device recalls. A record in it, the database says, "is created when a firm initiates a correction or removal action," and it is updated "if the FDA identifies a violation and classifies the action as a recall." Recall Z-1519-2025, posted on April 11, 2025, is headed as a Class 1 device recall. It concerns an insulin pump that works with a paired continuous glucose monitor, and the defect is in the pump's software. The record gives the quantity in commerce as 63 units. Parts of the record follow, not the whole.

A Trend Worked Out Wrong

The manufacturer's reason for the recall, as the record states it, is "a software defect in Version 7.9 of the pump software". It matters when the pump is used with the feature that adjusts insulin delivery by itself. Then, in the record's words, the defect "will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor."

What follows from it is in the record too. The wrong trend "can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia." Too little insulin can follow, or too much.

Nothing in the record says the pump stops, and it names no alarm that marks the wrong trend.

The Action

The record's account of the action says the manufacturer contacted each affected customer by phone on February 28, 2025, concerning an "Urgent Medical Device Correction," and followed up by email on March 11, 2025. The first instruction is to turn the automatic feature off immediately. The pump may still be used without it, and then, the record says, it "will deliver insulin based on your programmed active personal profile and will not automatically adjust insulin delivery."

The rest ask consignees to refer to the user guide that came with the pump, to keep using the pump as that guide describes, to "Pay attention to all system alerts and alarms," and to "Always carry back-up supplies."

What the Record Leaves Open

The record lists the recall's status as open and classified. A note on "open" says that "The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes."

The cause the FDA determined is a "Software Design Change." A second note adds that, per FDA policy, "recall cause determinations are subject to modification up to the point of termination of the recall."