Tandem Diabetes Care recalls insulin pumps over speaker malfunction

08/18/2025 / By Belle Carter

Tandem Diabetes Care, Inc. has announced a voluntary recall of its t:slim X2 insulin pumps due to a potential speaker-related issue that could disrupt insulin delivery, as reported by the FDA on August 12.
The malfunction, known as “Malfunction 16,” can cause the pump to stop insulin delivery and disconnect from continuous glucose monitoring (CGM) devices, potentially leading to hyperglycemia. Tandem has received 700 reports of adverse events, with 59 injuries but no fatalities.
Tandem notified affected U.S. customers between July 22 and 24, providing instructions on handling the malfunction and emphasizing the importance of having a backup insulin delivery method and monitoring blood sugar levels.
Tandem is developing a software update to enhance early detection of speaker failure and introduce persistent vibration alerts to improve safety. The company will notify users once the update is available and encourage prompt installation.
This is not the first recall for the t:slim X2 pump, as a previous software defect issue remains unresolved. The recurring problems highlight concerns about medical device reliability and the critical need for rigorous testing and quality control in the industry, especially given the high prevalence of diabetes and its severe health implications.

Tandem Diabetes Care, Inc. has announced a voluntary recall of its t:slim X2 insulin pumps due to a potential speaker-related issue that could disrupt insulin delivery, the Food and Drug Administration (FDA) reported on Aug. 12.

The t:slim X2 insulin pump, a device resembling a small cell phone, is designed to deliver insulin continuously – replacing the need for manual injections. However, the recent issue identified by Tandem could lead to a critical interruption in insulin delivery.

The malfunction manifests as a “Malfunction 16” alarm, which not only stops insulin supply but also disrupts the connection with continuous glucose monitoring devices that monitor glucose levels in real-time. This disruption can result in hyperglycemia, a condition characterized by high blood sugar levels.

According to Tandem’s announcement, the company has received 700 confirmed reports of adverse events related to high blood sugar and instances where users required medical intervention. Although no fatalities have been reported, 59 injuries have been documented.

The medical device manufacturer took swift action by notifying affected U.S. customers between July 22 and 24. The notice provided instructions on how to handle the malfunction, emphasizing the importance of having a backup method for insulin delivery and regularly monitoring blood sugar levels to prevent unexpected highs or lows.

Historical context: A pattern of recalls

In response to the issue, Tandem is developing a software update designed to improve the early detection of speaker failure. This update will also introduce persistent vibration alerts to mitigate potential safety risks. The company has pledged to notify all pump users once the software update is available and to encourage them to install it promptly.

This is not the first time Tandem has faced issues with its t:slim X2 insulin pump. Back in February, the company issued a separate recall due to a software defect that could cause the device to under-deliver or over-deliver insulin, leading to severe cases of hypoglycemia or hyperglycemia. The FDA’s recall status for that issue remains “open,” indicating that not all faulty products have been corrected or removed from the market.

The recurring problems with Tandem’s insulin pumps highlight broader concerns about the reliability of medical devices. According to a June 2022 study, approximately 350,000 people in the U.S. rely on insulin pumps – representing only a small fraction of the estimated 38 million American adults living with diabetes.

The Centers for Disease Control and Prevention (CDC) reports that one in five individuals with diabetes is unaware of their condition. Moreover, about one in three adults has prediabetes, a precursor to type 2 diabetes.

The recall underscores the critical need for rigorous testing and quality control in the medical device industry. Diabetes is the eighth leading cause of death in the U.S. and the number one cause of adult blindness, lower-limb amputations and kidney failure, according to the CDC. As the San Diego-based company works to rectify the speaker-related malfunction in its insulin pumps, users are advised to remain vigilant and follow the company’s instructions to ensure their safety. (Related: Twice-a-week fasting CRUSHES Type-2 Diabetes: Insulin resistance defeated by autophagy.)

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Watch the video below that talks about Type 1 diabetes being caused by insulin injection.

This video is from The Real Dr Judy channel on Brighteon.com.