Skip to content
type1.science

Tandem Mobi (pump)

Tandem Diabetes Care

What it is

A ~200-unit, miniature tubed pump (world's-smallest and less-than-half-the-X2 comparisons per cited articles; superlatives not verified verbatim in the pages read), controllable from a compatible phone, with a short detachable infusion set and wireless charging (charging/set specifics per cited product detail). It runs Control-IQ+ automation with Dexcom CGM compatibility reported in the sources read. Several FDA corrections remain open; the affected software/configuration and action differ by recall (recall scope per the cited records).

Editorial review: .

Most recent recorded citation date: 2026-08-06. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Available nowRegulator-approvedpumptubeddurablephone-control

Evidence behind this assessment

Key evidence notes. Study results, product eligibility and access answer different questions.

Who was studied?
Study populations and analysis groups vary. Product age limits alone do not describe who was studied.
Benefit or performance
Reliability: Built on Tandem's Control-IQ platform with occlusion alarms and reported real-world data (median ~71% time in range across 40,000+ users per the cited real-world source; full text not re-verified in this review), but three open FDA corrections cover a false Malfunction 12 that stops delivery, faulty glucose interpolation around CGM gaps, and an unexpected G7-paired autobolus. Exact versions and corrective actions differ.[1]
Important harms and treatment burden
Read the safety discussion and original sources. A missing summary does not establish safety.
Approval and country access
Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
Follow-up and remaining uncertainty
Read the full discussion and original sources for follow-up duration and study limitations.

This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.

Editorial score: calculation and evidence

A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.

Default calculation: 66 × 20 + 62 × 20 + 75 × 20 + 90 × 15 + 60 × 10 + 56 × 15 = 6850; divide by total weight 100. Unrounded weighted result: 68.5.

Interoperability66

Works in the US with Dexcom G6, G7 and G7 15 Day and runs Control-IQ+, but it is a closed commercial system (FreeStyle Libre exclusion and no open/DIY support per the compatibility page; page not opened in this review).

Reliability62

Built on Tandem's Control-IQ platform with occlusion alarms and reported real-world data (median ~71% time in range across 40,000+ users per the cited real-world source; full text not re-verified in this review), but three open FDA corrections cover a false Malfunction 12 that stops delivery, faulty glucose interpolation around CGM gaps, and an unexpected G7-paired autobolus. Exact versions and corrective actions differ.[1]

Form factor75

A miniature tubed pump (less-than-half-the-X2 and smallest-durable comparisons per cited articles; superlatives not verified verbatim in the pages read), but still tubed (short detachable set) rather than a true patch.

Phone control90

Fully controllable from a compatible phone app (iOS and Android), with an on-pump button as backup for app-free bolusing (clearance-date and button specifics per cited articles; not verified verbatim in this review).

Capacity60

~200-unit cartridge is smaller than the t:slim X2's ~300 units, trading wear duration for size; infusion-set change follows standard pump practice (2-3-day specifics per cited articles; not verified verbatim in this review).

Access & cost56

Established in the United States for ages 2+. Tandem reported that international commercial rollout began in Q2 2026, but did not name the initial countries, so access remains narrower and less certain than for the t:slim X2.[5]

The full picture

The Tandem Mobi is described as a miniature durable automated insulin delivery system — a small pump that can slip into the coin pocket of a pair of jeans (world's-smallest and less-than-half-the-X2 comparisons per cited articles; superlative not verified verbatim in the pages read).89 It is a tubed pump, not a patch, but it shrinks the tubed format dramatically: the small durable pump body connects to the body through a short, detachable infusion set (5-inch tubing and disconnect specifics per the cited article; body not captured in this review), so you can briefly disconnect to shower or swim.9

Reservoir and wear. The Mobi uses a clear ~200-unit insulin cartridge, smaller than the t:slim X2's ~300-unit cartridge (X2 comparison per the t:slim page; BT1 bodies not captured in this review), which is the trade-off for its size.89 The cartridge is paired with standard Tandem infusion sets, so the site/cannula is changed following standard pump practice (2–3-day specifics per cited articles; not verified verbatim in this review).9 The pump body itself is durable and rechargeable by wireless (inductive) charging, and it is described as water-resistant (IP28/8-feet/2-hour specifics per cited product detail; not verified verbatim in the pages read).10

Infusion set and occlusion detection. Because it is compatible with the full Tandem infusion-set range, users can mix and match cannula type, angle, and tubing length (mix-and-match specifics per cited articles; set range confirmed as "The system is compatible with all Tandem infusion sets").910 Like other Tandem pumps it is described as including occlusion (blockage) detection and alarms; as with any infusion-set pump, a kinked or bent cannula may not always trigger an alarm, so site rotation and monitoring still matter (occlusion-alarm and kink specifics per the cited review; not verified verbatim in this review).11

Recall — "Malfunction 12". The Mobi carries an FDA Class 1 recall (recall number Z-0427-2026, the FDA's most serious category, covering 17,745 units in commerce). A software-design fault could make the pump falsely detect a vibration-motor failure and raise "Malfunction 12": the pump then cannot operate, insulin delivery and any active CGM session stop, and the phone app can no longer receive data from the pump — which can lead to hyperglycemia and, untreated, to DKA.1 Only software versions 7.6.0.1, 7.6.0.3 and 7.7.0.1 are affected; for this Malfunction 12 issue specifically, an update to 7.9.0.2 or later is the fix. It does not resolve every other open Mobi correction. This is a correction, not a removal — the pumps stay on the market.1

Two other open software corrections have different actions. Class I Z-1520-2025 covers 85 Mobi pumps on Control-IQ+ software 7.9: faulty interpolation around a CGM data gap when the estimated glucose value exceeds 255 mg/dL can under- or over-deliver insulin, and the FDA-listed action says affected users should turn off Control-IQ+.2 Shared Class II Z-0232-2026 covers Mobi 7.9.0.1 (and named t:slim X2 versions) paired with Dexcom G7: starting a new sensor session too soon can trigger an unexpected automatic correction bolus and hypoglycemia, so affected users must follow Tandem's sensor-pairing timing instructions until the correction is installed.3 Exact software and configuration determine which notice applies.

Which CGMs and algorithms it works with. The Mobi is a closed commercial AID system. It integrates in the US with Dexcom G6, standard G7 and G7 15 Day (Q2-2026 timing per the cited filing; not verified verbatim in this review), and runs Tandem's Control-IQ+ algorithm, which reads CGM values, predicts glucose 30 minutes ahead, and automatically adjusts insulin (every-five-minutes cadence per cited product detail; not verified verbatim in the pages read).10124 It is described as a closed commercial system with no official DIY/open-source looping, and Abbott's FreeStyle Libre is not listed for the Mobi in the sources read (exclusion specifics per the compatibility page; page not opened in this review).13 The underlying Control-IQ algorithm was tested in the pivotal NEJM randomized trial (Brown et al.; 61%-to-71% figures per the cited trial record; full-text figures not re-verified in this review).14 Real-world Control-IQ+ data are reported from a large user cohort (40,000-user/71% figures per the cited real-world source; full text not re-verified in this review).15 Tandem is reported to cite up to 79% daytime and 90% overnight time in range (per the cited article; body not captured in this review).8

Phone bolusing. The Mobi is fully controllable from a compatible phone — you can bolus for meals directly from the app.10 iOS and Android phone-app control are reported in the cited articles (launch/clearance dates of February 2024 and 10 November 2025 and Pixel/Galaxy model lists per cited article bodies; bodies not captured in this review, with broad rollout in early 2026).98 A pump button is described as delivering a bolus without the phone as a backup (button specifics per the cited article; body not captured in this review).9

Pregnancy indication. On 27 April 2026 the FDA cleared Control-IQ+ on both Mobi and t:slim X2 for pregnancy complicated by type 1 diabetes; Tandem announced the corresponding European CE-mark expansion on 5 June (per the cited release excerpt; release not opened in this review).67 The randomized CIRCUIT evidence behind that label tested Control-IQ on t:slim X2 hardware, so it supports the shared algorithm and pregnancy indication rather than a Mobi-specific hardware trial.

Access and cost. The Mobi is established in the United States for people aged 2 and older.10 Tandem reported on 6 August 2026 that an international commercial rollout had begun during Q2, but its filing did not identify the first countries or support a claim of blanket availability across Europe, Canada or Australia.4 In the US it is distributed through durable-medical-equipment channels; exact out-of-pocket cost depends on insurance (distribution/cost specifics beyond the sources read in this review).

What's coming. Tandem is developing a tubeless version of the Mobi: the same pump body would slide into an adhesive patch (via a side-clip design) using a new 7-day SteadiSet infusion set, making it a first-of-its-kind hybrid that can be worn either tubed or tubeless.16 The company confirmed that it submitted the 510(k) in Q2 2026.4 Submission is not FDA clearance, so today Mobi remains a tubed pump and no launch date is assured.

What's next for this

  • →Tubeless version of the Mobi (pump body slides into an adhesive patch via side-clip, new 7-day SteadiSet); 510(k) submitted in Q2 2026 · FDA review pending
  • →Continued international rollout beyond the unnamed first markets · began in Q2 2026

Sources

  1. [1]
    Class 1 Device Recall: Tandem Mobi Insulin Pump with Interoperable Technology (Z-0427-2026) · Regulatory decision · 2025-11-05 — Software-design fault on versions 7.6.0.1, 7.6.0.3 and 7.7.0.1; 17,745 units in commerce. A correction, not a removal — remedy is a free software update to 7.9.0.2.

    U.S. Food and Drug Administration. Class 1 Device Recall: Tandem Mobi Insulin Pump with Interoperable Technology (recall Z-0427-2026; initiated 6 October 2025, posted 5 November 2025). accessdata.fda.gov (2025).

  2. [2]
    FDA Class I recall Z-1520-2025 — Tandem Mobi Control-IQ+ software 7.9 · Regulatory decision · 2025-04-11 — Open correction for 85 units. Incorrect interpolation around a CGM data gap when glucose exceeds 255 mg/dL can under- or over-deliver insulin; the FDA-listed action says to turn off Control-IQ+ on affected pumps.

    U.S. FDA. Class I Device Recall Tandem Mobi Control-IQ+ software 7.9 — Z-1520-2025 (open; 85 units; under-/over-delivery risk around CGM data gaps).

  3. [3]
    FDA Class II recall Z-0232-2026 — Tandem Mobi/t:slim X2 with Dexcom G7 · Regulatory decision · 2025-10-23 — Open correction covering Mobi 7.9.0.1 and specified t:slim X2 versions paired with G7. Sensor-session timing can trigger an unexpected autobolus; users must follow the pairing timing instructions until corrected.

    U.S. FDA. Class II Device Recall Tandem Mobi/t:slim X2 with Dexcom G7 — Z-0232-2026 (open; unexpected autobolus risk on named versions; follow sensor-pairing timing instructions).

  4. [4]
    Tandem Diabetes Care Announces Second Quarter 2026 Financial Results · Manufacturer · 2026-08-06 — SEC Exhibit 99.1 reports US G7 15 Day compatibility, submission of the tubeless-capability 510(k), and the start of international Mobi rollout. It does not identify the first non-US markets.

    Tandem Diabetes Care. Second Quarter 2026 Financial Results (US G7 15 Day compatibility; submitted tubeless-capability 510(k); international commercial rollout began). SEC Exhibit 99.1, 6 August 2026.

  5. [5]
    Tandem Mobi system — current indications for use · Manufacturer — Current US product page states that the Mobi pump and Control-IQ+ for T1D are indicated for people aged 2 years and older. Retrieved 2026-08-08.
  6. [6]
    Tandem Control-IQ+ receives FDA clearance for pregnancy in type 1 diabetes · Manufacturer · 2026-04-27 — The pregnancy indication applies to Control-IQ+ on both t:slim X2 and Mobi. CIRCUIT tested the algorithm on t:slim X2 hardware, not Mobi.

    Tandem Diabetes Care. Control-IQ+ automated insulin delivery technology now FDA cleared for pregnancy in type 1 diabetes (27 April 2026; applies to t:slim X2 and Mobi).

  7. [7]
    Tandem AID systems receive CE mark for type 1 diabetes during pregnancy · Manufacturer · 2026-06-05

    Tandem Diabetes Care. Automated insulin delivery systems receive CE mark for type 2 diabetes and type 1 diabetes during pregnancy (5 June 2026; applies to t:slim X2 and Mobi).

  8. [8]

    Beyond Type 1. Tandem Mobi Receives FDA Clearance for Use with Android Smartphones. beyondtype1.org (2025). https://beyondtype1.org/fda-approval-tandem-mobi-android/

  9. [9]

    Beyond Type 1. The Tandem Mobi is Now Available. beyondtype1.org (2024). https://beyondtype1.org/the-tandem-mobi-is-now-available/

  10. [10]

    Tandem Diabetes Care. Tandem Mobi Automated Insulin Delivery System. tandemdiabetes.com (accessed 2026). https://www.tandemdiabetes.com/products/insulin-pumps/tandem-mobi

  11. [11]

    Sawyer A, Forlenza GP, Wadwa RP. An overview of the t:slim X2 and Mobi insulin pumps with Control-IQ technology: patient safety and device efficacy. Expert Review of Medical Devices (2025). doi:10.1080/17434440.2025.2585061. https://pubmed.ncbi.nlm.nih.gov/41175172/

  12. [12]

    Beyond Type 1. Tandem Mobi Pump and the Dexcom G7 CGM Are Now Connected. beyondtype1.org (2024). https://beyondtype1.org/tandem-mobi-dexcom-g7-integration/

  13. [13]

    Tandem Diabetes Care. CGM Sensor Compatibility. tandemdiabetes.com (accessed 2026). https://www.tandemdiabetes.com/support/cgm-compatibility

  14. [14]

    Brown SA, Kovatchev BP, Raghinaru D, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. New England Journal of Medicine (2019). doi:10.1056/NEJMoa1907863. https://pubmed.ncbi.nlm.nih.gov/31618560/

  15. [15]

    Assadi KZ, D'Souza EW, Pinsker JE, Messer LH. First Use of Control-IQ+ Technology in Newly Indicated Populations. Diabetes Technology & Therapeutics (2026). doi:10.1177/15209156261456818. https://pubmed.ncbi.nlm.nih.gov/42267588/

  16. [16]

    Reuter E. Tandem to file tubeless insulin pump with FDA this quarter. MedTech Dive (2025). https://www.medtechdive.com/news/tandem-to-file-tubeless-insulin-pump-with-fda-this-quarter/819722/