Pharmacy Kit, Starter Pack, Tandem t:slim X2, Control IQ+ 1017064Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00389152706474), received between May 19, 2026 and Sep 29, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K232380); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Pumping Stopped

  It was reported that the pump experienced a malfunction after the pump got wet. There was no reported adverse impact to the customer¿s blood glucose level. The pump was replaced to resolve the issue, and the customer will use multiple daily injections (MDI) as a backup therapy until the replacement arrives.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935552 ↗
• MalfunctionSep 28, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924135 ↗
• MalfunctionAug 17, 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. The customer reverted to an alternate method of insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50284887 ↗
• InjuryJun 30, 2026Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. A MANUAL INSULIN INJECTION WAS ADMINISTERED TO ADDRESS BG LEVEL. REPORTEDLY, THE CUSTOMER WAS USING FIASP INSULIN WITH THE PUMP. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT FIASP INSULIN IS OFF-LABEL PER THE USER GUIDE. CUSTOMER CHANGED CARTRIDGE AND INFUSION SET TO ADDRESS THE ISSUE.

  Patient problems: Hyperglycemia

  MAUDE report 25670611 ↗
• MalfunctionJun 27, 2026Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER RESOLVED ISSUE BY CHANGING INFUSION SET AND CARTRIDGE AND RESUMING INSULIN. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT NOVOLOG INSULIN IS INDICATED FOR USE WITH TANDEM SUPPLIES FOR 3 DAYS. CUSTOMER UNDERSTOOD AND ACKNOWLEDGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644742 ↗
• MalfunctionJun 2, 2026False Alarm

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THERE WAS NO ADVERSE 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 25366077 ↗
• MalfunctionMay 21, 2026Pumping Stopped

  IT WAS REPORTED THAT CARTRIDGE ALARM 20 OCCURRED WHILE CUSTOMER USED PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, RECEIVED GUIDANCE TO LOAD NEW CARTRIDGE USING PROPER TECHNIQUE, SUCCESSFULLY RESUMED INSULIN DELIVERY, AND ISSUE WAS RESOLVED; NO ADDITIONAL OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241983 ↗
• MalfunctionMay 19, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER FAILED TO COMPLETE THE AIR REMOVAL STEP FOR CARTRIDGE. TANDEM CUSTOMER TECHNICAL SUPPORT EDUCATED CUSTOMER TO FOLLOW THE PROPER AIR REMOVAL STEPS. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219549 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232380. One submission often covers many models, so check the product and lot details in each record.

• Z-3330-2026 · Jul 16, 2026 · Open, Classified
  Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.1
• Z-1636-2026 · Jan 30, 2026 · Open, Classified
  Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a di
• Z-2621-2025 · Jul 3, 2025 · Open, Classified
  t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
• Z-1519-2025 · Feb 27, 2025 · Open, Classified
  t:slim X2 Insulin Pump with Interoperable Technology