Tandem Diabetes Recalls Insulin Pumps After 59 Reported Injuries

Tandem Diabetes Care, Inc., based in San Diego, has initiated a voluntary recall of its t:slim X2 insulin pumps following reports of 59 injuries related to the device. The announcement was made on August 12, 2023, in conjunction with the U.S. Food and Drug Administration (FDA).

The t:slim X2 insulin pump is designed to deliver insulin at specific intervals and doses, helping users manage their blood sugar levels effectively. These devices often include alarm functions intended to alert users to various operational issues, including problems with insulin delivery.

According to the FDA announcement, the recall aims to address a “potential speaker-related issue” that can cause a malfunction. This malfunction presents itself as a Malfunction 16 alarm, leading to the immediate cessation of insulin delivery. Furthermore, it disrupts communication between the insulin pump and any connected continuous glucose monitoring (CGM) devices.

The company emphasized that this issue could significantly impact users, as interrupted insulin delivery poses serious health risks. As a result, Tandem Diabetes is urging all users of the affected pumps to discontinue use immediately and to contact their healthcare providers for guidance on alternative treatment options.

The recalled models were distributed across various locations, and Tandem Diabetes has committed to providing support to those affected. Users with questions or concerns are encouraged to reach out to the company’s customer service for assistance.

In light of this significant recall, health experts recommend that patients closely monitor their blood sugar levels and remain vigilant for any symptoms that may arise due to the disruption in insulin delivery.

The FDA and Tandem Diabetes continue to investigate the issue, working to ensure that safety and reliability are restored for insulin pump users. The company has not yet disclosed the financial implications of this recall but has committed to addressing the concerns raised by this situation promptly.

As insulin pumps play a crucial role in diabetes management for many individuals, it is essential for users to stay informed and take appropriate actions to safeguard their health.