Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement

FDA device recall Z-2343-2025 · posted 2025-08-27 · Open, Classified

Recall details

Recalling firm

Tandem Diabetes Care, Inc.

Reason for recall

Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.

Action taken

On 7/21/2025, correction notices were mailed or emailed to customers were informed of the following: Confirm whether your pump is affected with serial number lookup: www.tandemdiabetes.com/mal16-2025 1) If you haven't had a Malfunction 16, continue using your Tandem pump as described in the User Guide, but with added precautions because the Malfunction 16 can occur at any time. 2) Use the Tandem t:slim mobile app with push notifications turned on so if the malfunction does occur, you will be notified by the app. If you need assistance with enabling smartphone notifications to receive alerts from your mobile app, go to support page: https://www.tandemdiabetes.com/support-center/software-and-apps/tandem-tslim-mobile-app/article/enable-smartphone-notifications-to-receive-alerts 3) If you are using a Dexcom sensor, use the Dexcom mobile app as a secondary means of CGM alerts and alarms. If you are unable to download and use the Tandem t:slim mobile app and/or your Dexcom mobile app, please contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com for support. 4) If you receive a Malfunction 16 alert: a. Promptly acknowledge it by pressing "Silence Alarm". b. Contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com to arrange for a replacement pump. c. Switch to your backup method of insulin delivery as directed by your physician. 5) Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. 6) Be prepared with a backup method of insulin delivery as directed by your physician, as set forth in the pump training, and as laid out in the pump user guide. 7) Complete the correction notice response form: campaign.tandemdiabetes.com/FCA-Malfunction-16 Firm is releasing a software update aimed at enhancing early detection of speaker failure and will notify users when available. If you have concerns, call 1-877-801-6901 or email Techsupport@tandemdiabetes.com.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

QFG

Quantity affected

171,750

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech Republic, Slovakia, Spain, United Kingdom, Belgium, Luxembourg, Australia, France, Italy, New Zealand, Finland, Sweden, Denma

Date initiated

2025-07-21

Date posted

2025-08-27

Location

San Diego, CA

Related 510(k) clearances