Device recall
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
- Recall number
- Z-3330-2026
- Event id
- 99589
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Tandem Diabetes Care, Inc.
- Report date
- Oct 7, 2026
- Posted
- Sep 29, 2026
- Initiated
- Jul 16, 2026
- Center classification date
- Sep 29, 2026
- Product code
- QFG
- Device type
- Alternate Controller Enabled Insulin Infusion Pump
- Reason
- A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia.
- Root cause
- Software Design Change
- Quantity
- 177
- Code info
- Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- San Diego, CA, United States