The Recall Desk
HighFDA (Devices)·Z-1812-2022·Announced 2022-10-05

t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management

Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a critical medical device with potential for serious health consequences (hypoglycemia, hyperglycemia, and diabetic ketoacidosis), but no reported illnesses or injuries are documented in the source material. The risk is significant but not yet confirmed through actual patient harm.

Plain-English summary

Tandem Diabetes Care Inc is recalling several versions of the t:slim X2 insulin pump, including models with Dexcom G5 integration, Basal-IQ technology, and Control-IQ technology. The recalled pumps are affected by software malfunctions that can cause four types of failures: Non-Volatile Memory malfunction, inaccurate battery life display, touchscreen remaining on, and unexpected open-loop operation. These issues could result in improper insulin delivery, leading to hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Approximately 8,399 affected pumps have been distributed throughout the United States, Puerto Rico, the U.S. Virgin Islands, and internationally in Australia, New Zealand, and South Africa. The recall affects the following software versions: t:slim X2 version 6.4.1 and earlier, t:slim X2 with Dexcom G5 versions 5.2.1 and 5.2.2, t:slim X2 with Basal-IQ versions 6.3.0.1, 6.4, and 6.4.1, and t:slim X2 with Control-IQ versions 7.4 and 7.4.3.

The FDA has classified this as a Class II recall. Tandem Diabetes Care has made a software update available that resolves these issues. Consumers with affected pumps should contact Tandem Diabetes Care to obtain and apply the software update.

The recalled product

Product
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Manufacturer
Tandem Diabetes Care Inc
Category
Medical Device — Insulin Pump
Hazard
Affected units
8,399

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 (8)

  • Insulin Pump/Software Versions: t:slim X2 insulin pump/6.4.1 and earlier
  • t:slim X2 insulin pump with Dexcom G5/5.2.1
  • 5.2.2
  • t:slim X2 insulin pump with Basal-IQ technology/6.3.0.1
  • 6.4
  • 6.4.1
  • t: slim x2 insulin pump with the Control-IQ Technology/7.4
  • 7.4.3

Distribution

Distributed in 53 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 →

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