Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Tandem t:slim mobile application version 2.13, iOS (TestFlight)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Tandem t:slim mobile application version 2.13, iOS (TestFlight)see related information
Date Initiated by FirmJuly 16, 2026
Date PostedSeptember 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3330-2026
Recall Event ID 99589
510(K)NumberK201214 K203234 K232380 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
ProductBrand 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
Code Information Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
FEI Number 3007981285
Recalling Firm/
Manufacturer		 Tandem Diabetes Care, Inc.
12400 High Bluff Dr
San Diego CA 92130-3077
For Additional Information ContactSusan Morrison
1-858-3666880
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software Design Change
ActionOn 07/16/2026, an "URGENT MEDICAL DEVICE CORRECTION" communication was sent via certified mail to customers informing them that an unexpected behavior was identified in the t:slim iOS mobile application version 2.13 made available through TestFlight. The issue involves users unable to pair a compatible FreeStyle Libre 3 Plus sensor after updating to version 2.13. If this occurs, the application will incorrectly display an "Incompatible Sensor" message and prevent sensor use. Customer are advised to: 1. Discontinue use of iOS t:slim mobile application version 2.13 2. Uninstall version 2.13 from their mobile device. 3. Return to the current production version of the t:slim mobile application (version 2.12.1) available on the Apple App Store. 4. Scan the compatible FreeStyle Libre 3 Plus sensor with version 2.12.1 when starting their next sensor session. For Questions - contact Tandum Customer Support at 1-877-801-6901 or email Techsupport@tandumdiabetes.com (24/7/365).
Quantity in Commerce177
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QFG
-
-