Tandem Mobi 1013700Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,314 adverse event reports that list this exact device (DI 00389152370019), received between Jul 5, 2024 and Sep 30, 2026 — classified as 1 death, 1,048 injuries, 5,265 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (2,934 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 6, 2025Class IOpen, Classified

   Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.

   Z-0427-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 6,314 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954991 ↗
• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952680 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937907 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935536 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  It was reported that ongoing intermittent occlusion alarms occurred. There was no adverse impact to the customer¿s blood glucose level. Customer changed infusion set and cartridge and resumed insulin to resolve the issue. The customer continued to use the pump for insulin therapy and has an alternate method of insulin therapy available if necessary.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934618 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  It was reported that occlusion alarms occurred on Mobi pump over the past week, and Technical Support was unable to verify alarm number. There was no adverse impact to the customer¿s blood glucose level. Customer changed infusion set and cartridge and resumed insulin, and due to ongoing occlusion issues despite changing all supplies, Technical Support arranged replacement pump, confirmed shipping details, instructed customer to use injected insulin as backup therapy, provided instructions to place pump in storage mode and return problematic pump within 10 days, and advised customer to enter pump settings and reconnect CGM on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933894 ↗
• MalfunctionSep 29, 2026Key or Button Unresponsive/not Working

  It was reported that the wake button on the pump was not working. There was no adverse impact on the customer's blood glucose level. The customer reverted to an alternate method of insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933259 ↗
• MalfunctionSep 29, 2026Air/Gas in Device

  It was reported that air bubbles were observed within the canister. Customer performed a supply change to address the issue. There was no adverse impact to the customer¿s blood glucose value.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932485 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  It was reported that pump displayed malfunction alarm code 12, which could be reset but alarm recurred after reset. There was no adverse impact to the customer¿s blood glucose level. Customer switched to multiple daily injections as backup insulin therapy, received guidance to reset pump, and was sent replacement pump with updated software; customer was instructed to put pump into storage mode, return problematic pump within 10 days using provided materials, and then program pump settings and reconnect continuous glucose monitor on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930837 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the customer experienced a blood glucose (BG) level that was displayed as ¿High¿; however, a specific value was not provided. Reportedly, the customer alleged the pump software did not accurately adjust the amount of insulin delivered resulting in the high BG. Customer gave a correction bolus via the pump to address BG level. Tandem Technical Support (CTS) performed a system check and performed a review of the pump data to determine a possible cause. CTS determined that the pump functioned as intended and the cause of the high BG was unknown, customer acknowledged and understood.

  Patient problems: Hyperglycemia

  MAUDE report 50923333 ↗
• InjurySep 28, 2026Obstruction of Flow

  It was reported that occlusion alarms repeatedly occurred during pump use, and customer noted ongoing occlusion issues even after changing all supplies. Customer¿s blood glucose (BG) level was reported as ¿High,¿ but specific value was unknown, and there was no indication of additional complications. Customer gave a correction dose through pump to address the BG level, changed infusion set and cartridge, and resumed insulin, and Technical Support arranged replacement pump and replacement infusion sets, provided instructions for backup insulin pump use and storage mode, and instructed customer to return problematic pump and set up settings and continuous glucose monitor on replacement device.

  Patient problems: Hyperglycemia

  MAUDE report 50917434 ↗
• InjurySep 28, 2026Pumping Stopped

  It was reported that pump displayed undertravel stall malfunction alarm, and blood glucose meter showed high value above meter range. Customer¿s blood glucose level exceeded 500 mg/dL, with exact value unknown. Customer gave correction insulin injection using multiple daily injections, switched to backup multiple daily injection therapy, and did not seek help from a third party. Technical Support arranged replacement pump with updated software, confirmed shipping details, provided instructions for storage mode and pump return, and advised customer to enter pump settings and reconnect continuous glucose monitor on replacement pump.

  Patient problems: Hyperglycemia

  MAUDE report 50915759 ↗
• MalfunctionSep 8, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671443 ↗
• MalfunctionSep 3, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591286 ↗
• MalfunctionAug 31, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50528382 ↗
• InjuryAug 20, 2026Obstruction of Flow

  It was reported that ongoing intermittent occlusion alarms occurred. Customer¿s blood glucose (BG) level was reported as ¿High¿ but specific value was unknown. Customer gave correction insulin by injection to address BG level. Reportedly, the customer continued to use the pump for insulin therapy and has an alternate method of insulin therapy available if necessary.

  Patient problems: Hyperglycemia

  MAUDE report 50355393 ↗
• InjuryAug 20, 2026Date/Time-Related Software Problem

  It was reported that the pump time was incorrect, cause was unknown. the customer experienced an elevated blood glucose (BG) level displayed as "High"; however, specific value was not provided. Customer gave a manual injection to address BG. During troubleshooting with Tandem Technical Support, the customer corrected the time and resumed insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50354215 ↗
• MalfunctionAug 20, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50346058 ↗
• MalfunctionAug 19, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330111 ↗
• MalfunctionAug 18, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307303 ↗
• MalfunctionAug 17, 2026Pumping Stopped

  It was reported that a malfunction alarm occurred. During troubleshooting with technical support, the malfunction alarm was cleared, and insulin delivery was resumed successfully. There was no reported adverse impact to the customer's blood glucose level.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280568 ↗
• MalfunctionAug 13, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234356 ↗
• MalfunctionAug 6, 2026Obstruction of Flow

  It was reported an occlusion alarm occurred. There was no adverse impact to the customer¿s blood glucose level. Customer followed troubleshooting instructions with Tandem Technical Support, occlusion was determined to be caused by blockage in cartridge, customer changed supplies as needed and resumed insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166845 ↗
• InjuryAug 6, 2026Obstruction of Flow

  It was reported intermittent occlusion alarms occurred. The customer's blood glucose level was displayed as "High"; a specific value was not provided. Elevated blood glucose was addressed with a manual dose injection. The customer changed supplies and resumed insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50166087 ↗
• InjuryAug 6, 2026Incorrect Measurement

  It was reported that the insulin gauge was inaccurate, triggering an empty cartridge alarm despite the cartridge not being empty. As a result, customer's blood glucose (BG) level was elevated at 479 mg/dL and had to go to the Emergency Room. Customer was subsequently hospitalized in the Intensive Care Unit where they were treated with intravenous fluids of saline and insulin. Treatment resolve the issue with no permanent damage to the customer. Multiple attempts were made by Tandem Technical Support to follow-up with the customer on the reported issue as well as to obtain the date of release from the hospital, but no response was received.

  Patient problems: Hyperglycemia

  MAUDE report 50162104 ↗