CLASS I ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report
t:connect mobile app used in conjunction recalled
Tandem Diabetes Care is recalling t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ, distributed nationwide in the US. The recall was initiated on 5 Mar 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1609-2024
- FDA event ID
- 94312
- Recalling firm
- Tandem Diabetes Care, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 5 Mar 2024
- FDA classified
- 6 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 5 Mar 2024 | Recall initiated by company | |
| 6 May 2024 | Classified by FDA | +62 days |
| 15 May 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Where it was distributed
US nationwide distribution including Puerto Rico.
Questions about this recall
Why was it recalled?
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Which lots are affected?
version 2.7 or later /UDI: 00850006613274
Where was it sold?
US nationwide distribution including Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tandem Diabetes Care
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tandem t:slim mobile application t:slim Mobile Application, iOS recalled | Tandem Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | Tandem pumps are battery-operated infusion pumps capable recalled | Tandem Diabetes Care | Device Malfunction | CA |
| Device | CLASS I | Tandem Mobi Insulin Pump: Description recalled by Tandem Diabetes Care | Tandem Diabetes Care | Device Malfunction | 52 states |
| Device | CLASS II | t:slim X2 insulin pump with Interoperable Technology recalled | Tandem Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | t:slim X2 Insulin Pump with Interoperable Technology recalled | Tandem Diabetes Care | Device Malfunction | CA |
Other Insulin Pumps & Glucose Monitors recalls
All 468| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The MiniMed Go app for iOS or MiniMed Go app recalled | Medtronic MiniMed | Device Malfunction | Nationwide |
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |