t:slim X2 Insulin Pump with Control-IQ 1009643Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Refurbished Replacement · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a refurbished Tandem t:slim X2 insulin pump with Control-IQ. Its reports mostly describe pump stoppages, battery and charging trouble, and communication problems. There are 51,223 reports, including 6 deaths and 5,331 injuries. One recall, started in July 2025, is open: it covers speakers that may fail and stop insulin delivery. Reports dropped to 5,992 in the last 12 months, from 13,237 before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51,110
- Deaths reported
- 7
- Injuries reported
- 5,337
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 51,110 adverse event reports that list this exact device (DI 00389152000107), received between Aug 25, 2022 and Sep 30, 2026 — classified as 7 deaths, 5,337 injuries, 45,766 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (17,201 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jul 21, 2025Open, 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 · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped17,201
- Battery Problem5,612
- Charging Problem5,423
- Communication or Transmission Problem4,056
- Incorrect Measurement3,913
- Obstruction of Flow2,753
- Adverse Event Without Identified Device or Use Problem2,459
- Failure to Sense2,146
Patient problems
- No Clinical Signs, Symptoms or Conditions45,780
- Hyperglycemia4,012
- Hypoglycemia1,276
- Elevated Ketones/ Diabetic Ketoacidosis244
- Loss of consciousness94
- Insufficient Information80
- Fall35
- Vomiting24
Recent adverse event reports
The 25 most recent of 51,110 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954855 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954739 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952513 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952296 ↗MalfunctionSep 30, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952013 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951706 ↗MalfunctionSep 30, 2026Charging Problem
It was reported that the customer was unable to charge the pump due to damage to the Tandem-provided USB charging cable and wall power adapter. There was no reported adverse impact to the customer's blood glucose level. A new charging cable and wall popwer adapter was sent to the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951445 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950186 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that the pump battery was depleting quickly. There was no adverse impact to the customer's blood glucose level. Customer declined to troubleshoot the issue with Tandem Technical Support, therefore no additional information was obtained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949515 ↗MalfunctionSep 30, 2026Fitting Problem
It was reported that customer experienced issue with cartridge fit, stating that cartridge felt loose when inserted and no longer made clicking sound. There was no reported impact to the customer¿s blood glucose level. Customer declined follow up from Technical Support, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949184 ↗MalfunctionSep 30, 2026Mechanical Problem
It was reported that multiple cartridge change errors occurred. There was no adverse impact to the customer's blood glucose level. Customer declined to troubleshoot the issue with Tandem Technical Support, therefore no additional information was obtained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948476 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
It was reported that pump screen remained dark and would not turn on despite multiple attempts, and caller observed red light blinking around button with no vibration or startup. There was no adverse impact to the customer¿s blood glucose level. Customer followed Technical Support instructions to press button, remove pump from case, and connect pump to working charger, but display still did not turn on, so pump was replaced and customer planned to use multiple daily injections as backup therapy while arranging for out-of-warranty loaner pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946977 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that the pump battery was depleting quickly. There was no reported adverse impact to the customer. The customer declined follow up from Tandem Technical Support regarding the issue. No additional patient or event information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946936 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported occlusion alarms occurred. There was no reported 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 50946918 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940836 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940811 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939756 ↗MalfunctionSep 29, 2026Priming Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937845 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937520 ↗MalfunctionSep 29, 2026Failure to Charge; Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936573 ↗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 50936553 ↗MalfunctionSep 29, 2026Scratched Material
It was reported that the pump touch screen was scratched and unreadable. 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 50936266 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the customer experienced a blood glucose (BG) level of 40 mg/dL, cause was unknown. Customer consumed carbohydrates to address BG level. Ultimately, the customer reverted to an alternate method of insulin therapy.
Patient problems: Hypoglycemia
MAUDE report 50936245 ↗MalfunctionSep 29, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935582 ↗MalfunctionSep 29, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935579 ↗
Other Alternate Controller Enabled Insulin Infusion Pump devices
- t:slim X2 Insulin Pump with Control-IQ 1006402Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls18 deaths159,247 reports
- t:slim X2 Insulin Pump with Control-IQ 1006408Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls12 deaths92,526 reports
- t:slim X2 Insulin Pump with Control-IQ 1009637Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall4 deaths83,884 reports
- Omnipod 5 Pod POD-BLE-H1-520Insulet Corporation · Alternate Controller Enabled Insulin Infusion Pump1 recall75 deaths71,459 reports
- Omnipod 5 Pod POD-OMNI-I1-6720Insulet Corporation · Alternate Controller Enabled Insulin Infusion Pump2 recalls11 deaths61,198 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1013198Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths47,637 reports
- t:slim X2 Insulin Pump with Control-IQ 1006404Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall18 deaths43,718 reports
- t:slim X2 Insulin Pump with Control-IQ 1005011Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths35,600 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.