More than 80,000 insulin pumps recalled due to safety risk—patients should follow latest instructions
California-based Tandem Diabetes Care is recalling more than 80,000 insulin pumps due to a risk of false-positive occlusion alarms. The recall includes several models of the company’s Tandem Mobi Insulin Pumps, which are battery-operated devices that provide both long-acting and short-acting bolus insulin doses.
Unlike many recalls, these devices can still be used for patient care. Tandem Diabetes care has provided specific recommendations patients should follow going forward to avoid any risk.
The reason for this recall
This recall was initiated due to an increased risk of false-positive occlusion alarms. These alarms are brought on by “increased friction within the drive module” that can impact motor speed. In some cases, this change in motor speed causes the pump to “incorrectly detect an occlusion condition and suspend insulin delivery.”
“When an occlusion alarm occurs, insulin delivery remains suspended until the user acknowledges the alarm and resumes therapy,” according to details provided by the U.S. Food and Drug Administration (FDA). “Repeated false-positive occlusion alarms, if not addressed promptly, may result in interruptions of insulin delivery that can increase the risk of elevated blood glucose levels. In severe cases, hyperglycemia may require medical intervention or hospitalization.”
The FDA has ruled this is a Class I recall, which means using the device without paying attention to this alert could lead to “serious adverse health consequences or death.”
What should patients do?
Patients are still able to use these devices, but there are certain recommendations they have been advised to follow. For example, users should always respond to occlusion alarms. This includes acknowledging the alarm, inspecting the device for signs of damage or blockage and correcting any issues that may impact insulin delivery. Also, users should make sure they have push notifications enable on their Tandem Mobi smartphone app so that they have a better chance of seeing any alarms.
Tandem Diabetes Caren is also urging users to be prepared to use a backup method of insulin delivery if necessary.
Which devices are impacted by this Class I recall?
A total of 80,938 insulin pumps have been recalled, including 77,559 distributed throughout the United States.
The specific model numbers included in this recall are 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018077 and 1018078.
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News comes nearly a year after another significant recall
Back in 2025, Tandem Diabetes Care recalled nearly 18,000 Tandem Mobi Insulin Pumps. That recall was put in place due to a possible software malfunction that could interfere with the delivery of insulin. No devices had to be returned, but a software update may have been necessary for certain patients.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.