Use caution Medical device recall · FDA · Published February 27, 2025

Tand:slim X2 Insulin Pump Software Defect May Cause Incorrect Glucose Readings

Tandem recalls t:slim X2 insulin pumps with software version 7.9 that may incorrectly interpret glucose trends, risking unsafe insulin delivery. Affected units sold with UDI 00389152407012.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1519-2025Medical device Tandem ›

Use caution until it’s fixed

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, 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, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

Take action

Contact the company

Recalling firmTandem Diabetes Care, Inc.12400 High Bluff Dr · San Diego, CA 92130-3077

✎ GovInfoNow plain-language explainer

Tandem is recalling t:slim X2 insulin pumps with software version 7.9 that may cause incorrect glucose readings when used with certain diabetes monitors. This could lead to dangerous insulin levels if the pump misinterprets high glucose values. Read more at govinfonow.com/recall/52733-tand-slim-x2-insulin-pump-software-defect-may-cause-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/52733-tand-slim-x2-insulin-pump-software-defect-may-cause-incorrect · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1519-2025

Cite this page

“Tand:slim X2 Insulin Pump Software Defect May Cause Incorrect Glucose Readings.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52733-tand-slim-x2-insulin-pump-software-defect-may-cause-incorrect. Based on FDA recall #Z-1519-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1519-2025%22&limit=1).

The FDA announced on Feb. 27, 2025, that Tandem Diabetes Care, Inc. is recalling t:slim X2 Insulin Pumps with Interoperable Technology due to a software defect that can cause inaccurate insulin delivery. The agency said the issue may lead to severe hypoglycemia or hyperglycemia.

How to tell if you have it

Brand: Tandem
Product: t:slim X2 Insulin Pump with Interoperable Technology
Software version: 7.9
UDI: 00389152407012
Units affected: 63

The hazard

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, 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. This can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

Context

GovInfoNow's records show Tandem Diabetes Care, Inc. has 10 other recalls on record since April 23, 2018. Other recent recalls of similar products include Medtronic MiniMed 780G Insulin Pump Recall: Software Error Causes Insulin Stoppage (May 27, 2026), Medtronic Paradigm Insulin Pumps Recall: Risk of Severe Hypoglycemia or Hyperglycemia (Feb. 13, 2026) and Medtronic MiniMed 780G Insulin Pump Software Version 6.60 Recall: Risk of Insulin Suspension (Nov. 2, 2025). FDA's MAUDE device-report database has received 36 reports naming slim X2 Interoperable since February 2024, with 2 marked serious.

How to tell if you have this one

Check for software version 7.9 on your t:slim X2 pump. Affected units have a unique device identifier (UDI) of 00389152407012.

Brand
Tandem
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A

Recall number	Product, codes & lots	Quantity
Z-1519-2025	t:slim X2 Insulin Pump with Interoperable Technology; Software versions 7.9/UDI: 00389152407012	63 units
Z-1520-2025	Tandem Mobi Insulin Pump with Interoperable Technology; Software versions 7.9/UDI: 00389152480114	85 units

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your pump's software version; if it's 7.9, it's affected.
Update Software
Contact Tandem to update to a newer software version that fixes this issue.

Where it went and when

Where it was distributed

Distributed in 29 states.

FDA distribution: “US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Maine, Maryland, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 55 days after the firm started it.

Feb 27, 2025Firm started the recall
Apr 11, 2025FDA classified it Class I
Apr 23, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52733-tand-slim-x2-insulin-pump-software-defect-may-cause-incorrect">Tand:slim X2 Insulin Pump Software Defect May Cause Incorrect Glucose Readings (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1519-2025 (February 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1519-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.