FDA Devices recall · Reported May 15, 2024
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
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 Bl…
Tandem Diabetes Care, Inc. recalled t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ tec… - a critical-severity action.
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ tec… was recalled by Tandem Diabetes Care, Inc. in May 15, 2024. Reason: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating …. Check the official notice for the remedy. Verify recall #Z-1609-2024 with the FDA Devices before acting.
The recall
Tandem Diabetes Care, Inc. issued this critical-severity FDA Devices recall-During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating ….
- Critical
- severity level
- Class I
- classification
- May 15, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1609-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1609-2024 |
| Date reported | May 15, 2024 |
| Date initiated | March 5, 2024 |
| Recalling firm | Tandem Diabetes Care, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 85,863 applications |
| Distribution | US nationwide distribution including Puerto Rico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1609-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026