t:slim X2 Insulin Pump with Control-IQ 1009641Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Medicare · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Tandem t:slim X2 insulin pump has 25,914 adverse event reports in the FDA database, including 8 deaths and 3,836 injuries. Recent reports often describe blockage alarms, pumps that stop working, and high blood sugar readings. There is 1 open recall, started in July 2025, because some pumps have speakers that may fail, silencing alerts and stopping insulin delivery. Reports in the last 12 months (3,515) are fewer than in the 12 months before (6,327).
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
- 25,864
- Deaths reported
- 8
- Injuries reported
- 3,830
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25,864 adverse event reports that list this exact device (DI 00389152000091), received between Sep 7, 2022 and Sep 30, 2026 — classified as 8 deaths, 3,830 injuries, 22,026 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (8,364 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 Stopped8,364
- Incorrect Measurement3,173
- Charging Problem2,414
- Adverse Event Without Identified Device or Use Problem2,352
- Communication or Transmission Problem1,839
- Filling Problem1,797
- Obstruction of Flow1,360
- Battery Problem1,341
Patient problems
- No Clinical Signs, Symptoms or Conditions22,013
- Hyperglycemia2,561
- Hypoglycemia1,241
- Elevated Ketones/ Diabetic Ketoacidosis196
- Loss of consciousness77
- Insufficient Information71
- Fall32
- Vomiting22
Recent adverse event reports
The 25 most recent of 25,864 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50955106 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955096 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954999 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954967 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954857 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952504 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952298 ↗MalfunctionSep 30, 2026False Alarm
It was reported that a cartridge alarm occurred indicating that the cartridge was over-filled despite the customer filling the cartridge with less than or equal to 300 units of insulin. There was no reported adverse impact to customer's blood glucose level. Reportedly, customer loaded a new cartridge to resolve the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951439 ↗MalfunctionSep 30, 2026Pumping Stopped
It was reported that an altitude alarm occurred. There was no reported impact to the customer's blood glucose. The customer declined assistance from Tandem Technical Support regarding the issues. No additional patient or event information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951198 ↗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 50950742 ↗InjurySep 30, 2026False Alarm
It was reported that pump declared altitude alarm and insulin delivery was suspended, and customer¿s blood glucose level was displayed as ¿High¿ above 500 mg/dL. There was an adverse impact to the customer¿s blood glucose level, but specific value was not known. Customer initially took no action and did not seek third-party assistance, while CTS provided instructions to clean speaker area, remove and reconnect cartridge, and attempt to resume insulin, which was not successful until customer loaded new cartridge and waited 2 hours for moisture to evaporate. After 2 hours, customer was able to load new cartridge, resume insulin delivery, and pump returned to normal operation, and CTS explained likely exposure to condensation or humidity, gave tips to prevent altitude alarms, and closed case with no further action required.
Patient problems: Hyperglycemia
MAUDE report 50950350 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported that customer experienced ongoing occlusion alarms on pump despite multiple troubleshooting attempts, including changing supplies, using longer cannula, and cleaning vents and tap, and caller confirmed occlusion alarm on reported event date. There was no adverse impact to the customer¿s blood glucose level. Customer resumed insulin therapy, was advised on how to continue using current pump and follow backup plan if needed, and Technical Support arranged pump replacement, instructed customer to place pump in storage mode, return pump properly, and watch for tracking email, with case closed after replacement was approved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950223 ↗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 50949812 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that the pump battery could not be charged. There was no reported adverse impact to the customer¿s blood glucose level. The customer will continue to use the current pump for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949190 ↗MalfunctionSep 30, 2026Scratched Material
It was reported that the pump touchscreen was excessively scratched, causing it to be delayed in responding to touch inputs. 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 50948865 ↗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 50948104 ↗MalfunctionSep 30, 2026Mechanical Problem
It was reported that ongoing cartridge alarms occurred during load sequence. There was no adverse impact to the customer¿s blood glucose value. Reportedly, customer continued using pump for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947685 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946950 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that the pump battery could not be charged. There was no reported adverse impact to the customer¿s blood glucose level. Reportedly, customer continued using pump for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946940 ↗MalfunctionSep 30, 2026Charging Problem
It was reported that the customer was unable to charge the pump using the Tandem-provided wall power adapter. There was no adverse impact to the customer¿s blood glucose value. Reportedly, the customer was able to successfully charge the pump using a secondary wall power adapter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946652 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938722 ↗MalfunctionSep 29, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938543 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938464 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938462 ↗MalfunctionSep 29, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938252 ↗
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 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.