Tandem Diabetes Care Issues Recall of t:slim X2 Insulin Pumps

Tandem Diabetes Care, Inc. has announced a voluntary medical device correction involving its t:slim X2 insulin pumps, following reports of a critical speaker-related issue. According to the U.S. Food and Drug Administration (FDA), this flaw can trigger a Malfunction 16 alarm, halting insulin delivery and disconnecting the pump from its continuous glucose monitoring (CGM) device. This failure puts patients at risk of severe hyperglycemia, potential hospitalization, and even life-threatening complications if not promptly addressed.

For patients who rely on these devices daily, the recall underscores the high stakes of medical device reliability. At KBD Attorneys, we have been closely following recalls in the medical care sector and advocating for those impacted by defective medical devices. This recall represents yet another reminder of why patient safety must remain at the forefront of medical device innovation.

Details of the Recall

• Company: Tandem Diabetes Care, Inc. (Nasdaq: TNDM)
• Product: t:slim X2 insulin pumps
• Issue: Speaker-related malfunction causing insulin delivery failure (Malfunction 16 alarm)
• Impact: Discontinuation of insulin delivery and loss of real-time CGM data
• Reports: 700 confirmed adverse events, 59 injuries, 0 deaths
• FDA Announcement Date: August 12, 2025
• Company Announcement Date: August 7, 2025

Notices were sent to impacted U.S. customers between July 22–24, 2025, with instructions on what to do if Malfunction 16 occurs. Tandem has also promised a software update that will improve early detection of speaker failures and add persistent vibration alerts to reduce patient risk.

Risks to Patients

The risk tied to this malfunction is substantial. When insulin delivery stops unexpectedly:

• Patients can quickly develop hyperglycemia (high blood sugar).
• Without timely intervention, hyperglycemia can escalate into diabetic ketoacidosis (DKA), a potentially fatal condition.
• The disruption of communication with the CGM device means patients lose access to real-time glucose trends, further complicating management.

The FDA has emphasized that while no deaths have been reported, the 700 confirmed adverse events—including 59 cases requiring medical intervention—highlight the seriousness of this recall.

Tandem’s Response

Tandem has stated it will release a software update to:

1. Enhance detection of speaker-related failures.
2. Provide persistent vibration alerts as a backup.

Pump users will be notified when the update is available and encouraged to complete it as soon as possible. For now, impacted customers can reach Tandem’s Technical Support Team 24/7 at (877) 801-6901 or via email at techsupport@tandemdiabetes.com. International customers are advised to contact their local distributor.

A Pattern of Device-Related Risks

At KBD Attorneys, we have written previously about medical device recalls and their consequences for patients. Defective diabetes management tools—from insulin pumps to CGMs—pose life-threatening risks when they fail.

This Tandem recall mirrors concerns raised in a prior case:

• Medtronic’s MiniMed 670G insulin pump recall (2019) due to retainer ring malfunctions that led to insulin dosing errors.

This similar recall illustrates a troubling pattern: devices that patients depend on to survive can themselves become sources of danger.

Legal and Patient Advocacy Considerations

For patients impacted by this recall, the consequences extend beyond health risks. Device malfunctions can lead to:

• Unexpected hospitalizations and medical expenses.
• Loss of trust in critical medical devices.
• Emotional distress for patients and their families.

From a legal standpoint, recalls raise questions about:

• Adequacy of testing and quality control before FDA clearance.
• Timeliness of reporting adverse events to regulators.
• Company responsibility for injuries tied to defective products.

At KBD Attorneys, we are actively monitoring the Tandem Diabetes Care recall. We continue to investigate potential claims on behalf of patients who have suffered injuries due to defective diabetes care devices.

What Patients Should Do

If you are a user of the t:slim X2 insulin pump:

1. Check your device’s serial number against the searchable list provided by Tandem at tandemdiabetes.com/mal16-2025.
2. Follow the instructions from the July 2025 customer notice.
3. Stay alert for Malfunction 16 alarms and seek immediate medical care if you experience high blood sugar that does not resolve.
4. Watch for Tandem’s software update notice and update your pump as soon as it becomes available.
5. Contact Tandem Support if you have questions or require assistance.

Conclusion

The recall of Tandem’s t:slim X2 insulin pumps is a sobering reminder of the vulnerabilities in even the most advanced medical technologies. For patients with diabetes, these devices are lifelines—and when they fail, the consequences can be devastating. While Tandem is taking steps to mitigate the risks, the volume of reported adverse events highlights the urgent need for stronger quality control, more transparent reporting, and a patient-first approach in medical device manufacturing.

At KBD Attorneys, we will continue to advocate for patients impacted by defective devices. As recalls like this one demonstrate, vigilance and accountability are essential to ensure that medical technology fulfills its promise: to heal, not to harm.

Contact us if you have been harmed by any medical device.