Pump, Infusion, Insulin
Tandem Diabetes Care, Inc.'s record for this product code
MDR events15,060All time
Recalls1All time
510(k) clearances7All time
Recent MDR events
15,060 adverse event reports on file
- TSLIM INSULIN PUMP X2Jun 17, 2026InjuryMW5189597
- TANDEM T-SLIM INSULIN PUMPOct 29, 2025InjuryMW5178191
- TANDEM TSLIM X2 INSULIN PUMPSep 22, 2025InjuryMW5176344
- TANDEM TSLIM X2 INSULIN PUMPJun 2, 2025InjuryMW5170969
- TANDEM T-SLIMMay 5, 2025InjuryMW5169932
- T SLIM TANDEM INSULIN PUMPFeb 21, 2025InjuryMW5166615
- T-SLIM 2Aug 21, 2024InjuryMW5158712
- TANDEM X2 INSULIN PUMPDec 18, 2023InjuryMW5149360
- TSLIM X2Nov 7, 2023InjuryMW5147887
- TANDEMNov 1, 2023MalfunctionMW5147672
Recalls
1 recall events for this product code
510(k) clearances
7 clearances for this product code
- K162080Oct 25, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
- K160056Jul 25, 2016
t:slim Insulin Delivery System
- K160482Jul 13, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
- K143189Jan 9, 2015
t:flex Insulin Delivery System
- K141758Oct 31, 2014
T:SLIM INSULIN DELIVERY SYSTEM
- K133593Mar 24, 2014
T:SLIM INSULIN DELIVERY SYSTEM
- K111210Nov 9, 2011
T:SLIM (TM) INSULIN DELIVERY SYSTEM