t:slim X2 Insulin Pump with Basal-IQRecalls & reported problems across all models

We found 14 models of t:slim X2 Insulin Pump with Basal-IQ by Tandem Diabetes Care, Inc. in the FDA's device registry (GUDID). Together they are named in 195,037 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2018 and Sep 30, 2026 — classified as 28 deaths, 18,107 injuries, 176,902 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (38,062 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

t:slim X2 Insulin Pump with Basal-IQ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 21, 2025Class IOpen, Classified

   Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.

   Z-2343-2025 · Root cause: Nonconforming Material/Component · names 5 of these models · Recall details · FDA record ↗

2. May 24, 2022Class IIOpen, Classified

   Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.

   Z-1811-2022 · Root cause: Device Design · names 10 of these models · Recall details · FDA record ↗

Most reported t:slim X2 Insulin Pump with Basal-IQ problems

t:slim X2 Insulin Pump with Basal-IQ models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• t:slim X2 Insulin Pump with Basal-IQ 1000886

  Automated Insulin Dosing , Threshold Suspend
  1 recall17 deaths108,656 reports
• t:slim X2 Insulin Pump with Basal-IQ 1000912

  Automated Insulin Dosing , Threshold Suspend
  1 recall2 deaths30,219 reports
• t:slim X2 Insulin Pump with Basal-IQ 1006379

  Alternate Controller Enabled Insulin Infusion Pump
  2 recalls16,712 reports
• t:slim X2 Insulin Pump with Basal-IQ 1000898

  Automated Insulin Dosing , Threshold Suspend
  1 recall6 deaths16,106 reports
• t:slim X2 Insulin Pump with Basal-IQ 1006373

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall7,488 reports
• t:slim X2 Insulin Pump with Basal-IQ 1000892

  Automated Insulin Dosing , Threshold Suspend
  1 recall1 death5,216 reports
• t:slim X2 Insulin Pump with Basal-IQ 1005706

  Automated Insulin Dosing , Threshold Suspend
  1 recall2 deaths5,094 reports
• t:slim X2 Insulin Pump with Basal-IQ 1009636

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall1,403 reports
• t:slim X2 Insulin Pump with Basal-IQ 1005698

  Automated Insulin Dosing , Threshold Suspend
  1 recall1,316 reports
• t:slim X2 Insulin Pump with Basal-IQ 1006375

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall1,016 reports
• t:slim X2 Insulin Pump with Basal-IQ 1009640

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall765 reports
• t:slim X2 Insulin Pump with Basal-IQ 1006377

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall520 reports
• t:slim X2 Insulin Pump with Basal-IQ 1009638

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall458 reports
• t:slim X2 Insulin Pump with Basal-IQ 1009639

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall68 reports

Recent t:slim X2 Insulin Pump with Basal-IQ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954761 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  It was reported that the pump touch screen was unresponsive. Customer declined follow up from Tandem Technical Support. There was no reported adverse impact to the customer. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947726 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938528 ↗
• MalfunctionSep 29, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938238 ↗
• MalfunctionSep 29, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938218 ↗
• MalfunctionSep 29, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937909 ↗
• InjurySep 29, 2026Use of Device Problem

  It was reported that the pump battery was depleting quickly resulting in the pump shutting off. Customer's blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. Customer administered a manual insulin injection to address elevated BG. Troubleshooting with Tandem Technical Support indicated that pump battery was depleting normally based on settings and customer usage. The customer continued to use the pump for insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50937592 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  A malfunction was reported on the pump. There was no reported adverse impact to the customer's blood glucose level. Technical Support provided information to reset the pump, assisted the caller with the reset, and confirmed that the malfunction code did not recur. The customer was advised to continue using the pump for insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937537 ↗
• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936575 ↗
• MalfunctionSep 29, 2026Failure to Charge

  It was reported that the customer received a power source alert after plugging the pump into a wall outlet. There was no reported adverse impact to the customer's blood glucose level. Multiple attempts were made by Tandem Technical Support to follow-up with the customer on the reported issue, but no response was received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935885 ↗
• MalfunctionSep 29, 2026Audible Prompt/Feedback Problem

  It was reported that the pump's alarm volume were too low. There was no adverse impact to the customer¿s blood glucose level. The customer declined follow-up from Tandem Technical Support regarding the issue, therefore no additional information was obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934600 ↗
• MalfunctionSep 29, 2026Incorrect Measurement

  It was reported that the battery gauge was inaccurate. There was no reported impact to the customer's blood glucose level. No additional information was provided and the customer declined troubleshooting with Tandem Technical Support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933987 ↗
• MalfunctionSep 29, 2026Incorrect Measurement

  It was reported that the battery gauge was fluctuating. There was no reported impact to the customer's blood glucose level. No additional information was provided and the customer declined troubleshooting with Tandem Technical Support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933955 ↗
• MalfunctionSep 29, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932927 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  It was reported that pump malfunction alarm occurred. There was no adverse impact to the customer¿s blood glucose level. Caller had no backup insulin therapy available and planned to contact healthcare provider, and Technical Support arranged replacement pump under warranty, confirmed shipping details, instructed caller to place pump in storage mode, and advised caller to return malfunctioning pump within 10 days and to program pump settings into replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927048 ↗

Other Tandem Diabetes Care, Inc. products

• t:slim X2 Insulin Pump45 models · 897,233 reports · 4 recalls
• t:slim X2 Insulin Pump with Control-IQ11 models · 522,176 reports · 2 recalls
• t:slim X2 Insulin Pump with Control-IQ Technology11 models · 126,966 reports · 3 recalls
• Tandem Mobi7 models · 51,239 reports · 3 recalls
• t:slim X2 5.0 Insulin Pump5 models · 41,241 reports · 2 recalls
• t:slim X2 Insulin Pump2 models · 8,967 reports · 1 recall