t:slim X2 Insulin Pump with Control-IQ 1009637Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Control-IQ, 7.6.x · 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 Tandem t:slim X2 insulin pump with Control-IQ. Its reports mostly describe pump stoppages, communication problems, battery drain and repeated occlusion alarms, some describing high blood glucose afterward. There are 84,241 reports, including 4 deaths and 8,883 injuries. One recall, started in July 2025, is open: it covers speakers that may fail and stop insulin delivery.
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
- 83,884
- Deaths reported
- 4
- Injuries reported
- 8,872
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 83,884 adverse event reports that list this exact device (DI 00389152000077), received between Aug 22, 2022 and Sep 30, 2026 — classified as 4 deaths, 8,872 injuries, 75,008 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (35,403 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 Stopped35,403
- Communication or Transmission Problem7,338
- Battery Problem6,725
- Incorrect Measurement6,654
- Charging Problem6,116
- Obstruction of Flow4,431
- Adverse Event Without Identified Device or Use Problem3,910
- Filling Problem2,970
Patient problems
- No Clinical Signs, Symptoms or Conditions75,125
- Hyperglycemia6,692
- Hypoglycemia2,017
- Elevated Ketones/ Diabetic Ketoacidosis420
- Insufficient Information113
- Loss of consciousness104
- Fall44
- Vomiting39
Recent adverse event reports
The 25 most recent of 83,884 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026False Alarm
Patient problems: Hyperglycemia
MAUDE report 50954985 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954983 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954868 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954850 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954748 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954738 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954256 ↗MalfunctionSep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952887 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952716 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952713 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952698 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952517 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952503 ↗MalfunctionSep 30, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952303 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952020 ↗InjurySep 30, 2026False Alarm
Patient problems: Hyperglycemia
MAUDE report 50951997 ↗MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951993 ↗MalfunctionSep 30, 2026Pumping Stopped
It was reported that an altitude alarm occurred. There was no reported impact to the customer's blood glucose. Reportedly, the cartridge was reloaded, and insulin delivery was resumed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951714 ↗MalfunctionSep 30, 2026Fracture
It was reported that the pump touchscreen was "missing completely" and customer can "see the circuit board". There was no adverse impact to the customer¿s blood glucose level. The customer reverted to manual injections for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951710 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection; Charging Problem
It was reported that the pump's USB port was loose, and the pump battery intermittently could not be charged properly without the customer maneuvering the cable into the charging port at a certain angle. 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 50951202 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection; Charging Problem
It was reported that the pump's USB port was loose, and the pump battery intermittently could not be charged properly without the customer maneuvering the cable into the charging port at a certain angle. 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 50951199 ↗MalfunctionSep 30, 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 50951117 ↗InjurySep 30, 2026Mechanical Problem
It was reported that pump declared cartridge change error without alarm, and customer¿s blood glucose level exceeded 500 mg/dL with value displayed as ¿High.¿ Customer experienced adverse impact to blood glucose level due to reported issue. Customer gave correction injection using multiple daily injections and did not require help from another person, then, with guidance from Technical Support, inspected cartridge O-ring and pump area, cleaned pneumatic tap, reattached cartridge, and followed on-screen steps to complete load process, after which customer successfully resumed insulin delivery.
Patient problems: Hyperglycemia
MAUDE report 50950752 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950746 ↗MalfunctionSep 30, 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 50950721 ↗
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
- 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 1009643Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall7 deaths51,110 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.