Twenty insulin pumps are still out there after shipping without their verification tests

Twenty MiniMed Flex insulin pumps remain in the field after leaving the factory with missing or failed results in the manufacturer’s own verification testing. Medtronic MiniMed, Inc. of Northridge, California started the recall on Aug. 20, 2026, and the Food and Drug Administration posted it in its recall database as a Class II action, number Z-0088-2027, with an enforcement report date of Oct. 14, 2026.

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The pumps are a small lot: 25 units were in commerce, and the company later reported that 20 were still in the field. The number is small, but the device is one that people wear and rely on around the clock to deliver insulin, which is why the manufacturer’s notice tells wearers to stop using an affected pump instead of waiting for a repair.

What the testing gap covers

The FDA’s recall record describes the MiniMed Flex as an alternate controller enabled pump, a device for subcutaneous insulin delivery that works with compatible continuous glucose monitors and runs through the MiniMed app. The reason for the recall is that some pumps were released with missing test results, or with a failed result, in one or more of nine functional tests. The record classifies the action as voluntary and firm-initiated, and the FDA lists the cause as under investigation by the firm.

The record lists what an untested pump may do: be inoperable at setup, resist moisture poorly, charge slowly, disconnect from the sensor or the app, detect blockages in the insulin line less reliably, play alarms too quietly or not at all, or deliver insulin inaccurately. MiniMed’s safety notice adds the clinical stakes in its own words: the problems could lead to delayed therapy, low or high blood sugar, diabetic ketoacidosis or death. The notice calls the pumps “released to customers with incomplete manufacturing testing.”

Which tests were skipped is not stated. The notice says only that testing was incomplete, and the FDA record says the cause is still being investigated.

Twenty pumps, two model numbers

The FDA’s device enforcement data is the source for the unit counts. The quantity field reads 25, and its code information splits those into 20 units of model MMT-8072 and five of model MMT-8062, adding that the final number of pumps still in the field is 20. The company’s recall notice in PDF form lists 20 serial numbers in its appendix, running from FB00010465 to FB00019307, and gives the model as MMT-8072. Its issue description, however, refers to MMT-8062, and the notice does not explain the difference.

The gap between 25 and 20 reflects pumps that are no longer with customers; the FDA page says some were returned or went to team members of the company. The 20 is therefore the number the firm reported as remaining after those adjustments, not the number first identified, and it is the figure that matches the 20 serial numbers in the company’s own appendix. Because the firm initiated the recall in August and the FDA classified it in October, the two documents are separated by roughly two months, and the count of 20 appears in both.

The FDA’s distribution pattern is nationwide, with 17 states named: Arkansas, Arizona, Colorado, Florida, Kansas, Kentucky, Louisiana, Michigan, Minnesota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas and West Virginia. A state list describes where units were shipped, not where wearers are, and the record does not report how many patients are involved.

What wearers of an affected pump are told

MiniMed’s notice gives three steps. A wearer of an affected Flex pump is told to stop using it and switch to the backup insulin plan already in place, then to call the recall line at (844) 885-0259 and say “Flex” at the prompt, which triggers an overnight shipment of a replacement pump. The third step is to confirm that the notice was read and followed by returning the confirmation form, scanning the QR code on the letter or using the web address printed on it. The company also lists a 24-hour technical support line at 1-800-646-4633, option 1.

The record notes that customers who could not be reached by phone are to receive an urgent recall letter by mail. The FDA page lists the recall as ongoing, which means not every unit has been corrected or removed, and the page was last updated on Oct. 15, 2026.

Evidence of harm is thin so far. As of Aug. 20, 2026, the notice reports three complaints of pumps failing to turn on at first use and says no adverse events have been reported to date. The same notice states that the recall is being reported to the FDA, and it points anyone who experiences a problem to the agency’s MedWatch reporting page or to the phone and fax numbers printed in the letter. The notice and the FDA record give no further instructions beyond these steps, so questions about managing insulin in the interim fall to the wearer’s own care team and the manufacturer’s support line.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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