t:slim X2 Insulin Pump with Control-IQ 1006408Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Refurbished Replacement · Class 2
2 open recalls name 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. Its reports mostly describe pump stoppages, charging trouble, incorrect measurements and battery problems. There are 92,553 reports, including 12 deaths and 8,640 injuries. Two recalls are open: one covers speakers that may fail and stop insulin delivery, the other covers memory, battery display and touchscreen problems. Reports dropped to 2,608 in the last 12 months, from 9,437 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
- 92,526
- Deaths reported
- 12
- Injuries reported
- 8,643
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 92,526 adverse event reports that list this exact device (DI 00850006613793), received between Aug 19, 2020 and Sep 30, 2026 — classified as 12 deaths, 8,643 injuries, 83,871 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (27,431 reports).
2 FDA recall records name this device's 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, 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 ↗
- May 24, 2022Open, 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 · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped27,431
- Charging Problem9,979
- Incorrect Measurement9,502
- Battery Problem8,934
- Failure to Sense7,206
- Obstruction of Flow6,142
- Adverse Event Without Identified Device or Use Problem4,766
- Communication or Transmission Problem4,092
Patient problems
- No Clinical Signs, Symptoms or Conditions82,810
- Hyperglycemia5,701
- Hypoglycemia2,775
- No Consequences Or Impact To Patient878
- Elevated Ketones/ Diabetic Ketoacidosis570
- Insufficient Information225
- No Known Impact Or Consequence To Patient179
- Loss of consciousness119
Recent adverse event reports
The 25 most recent of 92,526 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951980 ↗MalfunctionSep 30, 2026Incorrect Measurement
It was reported that insulin gauge displayed amount different than expected earlier in the day, showing 32 units when caller expected 145 units, with difference greater than 30 units. There was no reported impact to the customer¿s blood glucose level. Caller resolved issue by reloading same cartridge, and Technical Support advised caller to call back for troubleshooting if issue occurred again, which caller acknowledged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949147 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948009 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the customer experienced a blood glucose (BG) level of 425 mg/dL, with ketones a healthcare provided identified as life threatening. Cause was unknown. Customer went to the emergency room (ER) and was admitted into the intensive care unit. Customer was treated with intravenous fluids of saline and insulin. Customer was released from the hospital on (b)(6) 2026 with the issue resolved and no permanent damage. Tandem Technical support performed a full pump system check and verified that pump was operating appropriately and customer continued to use the pump for insulin therapy.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50945807 ↗MalfunctionSep 29, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941319 ↗MalfunctionSep 29, 2026Loose or Intermittent Connection; Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937249 ↗MalfunctionSep 29, 2026Key or Button Unresponsive/not Working
It was reported that the wake button on the pump was sticking and had to be pressed with extra force in order to turn the pump screen on. 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 50936899 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936532 ↗MalfunctionSep 29, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935920 ↗InjurySep 28, 2026Fracture
Patient problems: Hyperglycemia
MAUDE report 50926142 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924168 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924146 ↗MalfunctionSep 28, 2026Pumping Stopped
It was reported that a cartridge alarm occurred during insulin delivery. Customer reverted to an alternate method of insulin therapy. There was no adverse impact to the customer¿s blood glucose level.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923657 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922268 ↗MalfunctionSep 28, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919480 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918334 ↗MalfunctionSep 28, 2026Mechanical Problem
It was reported that pump displayed a cartridge change error and customer continued to receive alerts despite multiple attempts to change cartridge. There was no adverse impact to the customer¿s blood glucose level and it did not exceed 500 mg/dL. Customer inspected cartridge and pump area, removed extra O-ring, cleaned pump connection, and attempted to reload cartridge but was not able to complete load process; Technical Support escalated case, advised customer to contact healthcare provider or local hospital for backup insulin therapy, and CSA later guided customer through loading new cartridge with room temperature insulin and new supplies, but error continued, customer stated they did not want to continue with Tandem, ended call, and no further action was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917137 ↗InjurySep 28, 2026Pumping Stopped
Patient problems: Hyperglycemia
MAUDE report 50915087 ↗MalfunctionAug 21, 2026Obstruction of Flow
It was reported that occlusion alarms occurred. 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 50380027 ↗MalfunctionAug 21, 2026Failure to Charge
It was reported that t:slim X2 pump battery would not charge and a power source alert appeared in pump history. There was no reported impact to the customer¿s blood glucose level. Customer was instructed to leave pump connected to working wall outlet with Tandem charging cable and adapter for at least 30 minutes, and technical support attempted follow-up by phone and email before closing case, with no additional information received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50369283 ↗MalfunctionAug 20, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50357642 ↗MalfunctionAug 20, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50357630 ↗MalfunctionAug 20, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356525 ↗MalfunctionAug 20, 2026Insufficient Device Problem Information
It was reported that customer was unable to load new cartridge, so customer used injections. There was no reported impact to the customer¿s blood glucose level. Customer declined further follow-up with Technical Support, used injections as alternate insulin therapy, and was in process of pump renewal through insurance.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354212 ↗MalfunctionAug 20, 2026Premature Discharge of Battery; Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50350343 ↗
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 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
- 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.