The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1519-2025·Announced 2025-04-23

t:slim X2 Insulin Pump Software Defect Affecting Glucose Delivery

Tandem Diabetes Care is recalling 63 units of the t:slim X2 Insulin Pump with software version 7.9 due to a defect that can cause incorrect insulin delivery. The defect may lead to dangerous blood sugar levels when glucose monitoring loses connection.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall of a medical device that can cause severe hypoglycemia or hyperglycemia due to incorrect insulin delivery. Class I medical device recalls with risk of serious harm are scored as Severe (4) when no deaths are reported.

Plain-English summary

Tandem Diabetes Care, Inc., is recalling the t:slim X2 Insulin Pump with Interoperable Technology (software version 7.9, UDI 00389152407012) due to a software defect that affects insulin delivery accuracy. The defect occurs when the pump is used with Control IQ+ technology and loses connection with a continuous glucose monitor (CGM) sensor while the glucose reading is above 255 mg/dL. In these situations, the pump incorrectly calculates glucose trends, which can result in under-delivery or over-delivery of insulin.

This software defect can lead to severe cases of hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar) because the insulin dosing is based on inaccurate glucose information. Approximately 63 units have been distributed across multiple U.S. states including Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Maine, Maryland, Michigan, Missouri, Mississippi, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.

Patients using the affected pumps should contact Tandem Diabetes Care for guidance. Tandem will provide a software update to correct the defect. Users should not discontinue insulin therapy without medical advice.

The recalled product

Product
t:slim X2 Insulin Pump with Interoperable Technology
Manufacturer
Tandem Diabetes Care, Inc.
Category
Medical Device — Insulin Pump / Drug Delivery System
Hazard
Affected units
63

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software versions 7.9/UDI: 00389152407012

Distribution

Distributed in 29 states:

Part of a larger recall action

This product is one of 2 recalled by Tandem Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Tandem Diabetes Care, Inc.

See all →

Same hazard · insulin delivery error

See all →

Similar recalls