🔍 RecallPedia

t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

Class I - Dangerous
🏥 Medical Devices Recalled: March 5, 2024 Tandem Diabetes Care Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    version 2.7 or later /UDI: 00850006613274
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Tandem Diabetes Care, Inc.
Reason for Recall:
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

Product Codes/Lot Numbers:

version 2.7 or later /UDI: 00850006613274

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1609-2024

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Tandem Diabetes Care

Class I - Dangerous

Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.

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Tandem Diabetes Care

Class I - Dangerous

A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.

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