T:slim Insulin Delivery System Insulin Infusion Pump
FDA Device Recall #Z-0827-2014 — Class I — January 10, 2014
Recall Summary
| Recall Number | Z-0827-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | January 10, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tandem Diabetes Care Inc |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 12, 807 boxes (10packs) |
Product Description
T:slim Insulin Delivery System Insulin Infusion Pump
Reason for Recall
Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
Distribution Pattern
USA (nationwide)
Lot / Code Information
Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120.
Other Recalls from Tandem Diabetes Care Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1811-2022 | Class II | t:slim X2 insulin pump; t:slim X2 insulin pump ... | May 24, 2022 |
| Z-1812-2022 | Class II | t:slim X2 insulin pump; t:slim X2 insulin pump ... | May 24, 2022 |
| Z-1258-2022 | Class II | t:slim X2 Insulin Pump with Dexcom G5 Mobile CG... | Sep 10, 2020 |
| Z-2471-2018 | Class II | t:slim G4 Insulin Pump with Dexcom G4 Platinum ... | Apr 23, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.