t:slim G4 Insulin Pump, Reconditioned Replacement 008114Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00852162004613), received between Dec 23, 2025 and Aug 6, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P140015); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160330 ↗
• MalfunctionJul 2, 2026Failure to Power Up

  IT WAS REPORTED THAT THE PUMP BATTERY WAS UNRESPONSIVE AND "WOULD NOT START" AFTER A SHUT DOWN. 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 25692471 ↗
• MalfunctionMar 11, 2026Failure to Charge

  THE CUSTOMER REPORTED THAT THEIR OLD G4 PUMP WOULD NOT TURN ON AFTER PLUGGING IN THE CHARGING CABLE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO KEEP THE PUMP CHARGING WITHOUT TOUCHING THE BUTTON, WHICH RESULTED IN THE PUMP TURNING ON. THE CUSTOMER PLANS TO USE THE G4 PUMP AS A BACKUP UNTIL A REPLACEMENT PUMP IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570836 ↗
• MalfunctionJan 28, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH TURNING ON A LEGACY PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE, INSTEAD DECIDING TO WAIT TO SPEAK WITH A HEALTHCARE PROFESSIONAL, AS THEY WERE IN THE PROCESS OF ACQUIRING ANOTHER PUMP. TECHNICAL SUPPORT THEN CLOSED THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199773 ↗
• InjuryJan 15, 2026Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BG WAS ADDRESSED BY A CORRECTION BOLUS VIA THE PUMP. CUSTOMER CHANGED THE CARTRIDGE ONLY AND RESUMED INSULIN.

  Patient problems: Hyperglycemia

  MAUDE report 24089478 ↗
• MalfunctionJan 8, 2026Mechanical Problem

  A CARTRIDGE CHANGE ERROR WAS REPORTED BY THE CUSTOMER WITH THEIR PUMP. THERE WAS NO ADVERSE IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO REMOVE THE CARTRIDGE, INSPECT THE O-RING, AND CLEAN THE PUMP AREA. DESPITE THESE STEPS AND ASSISTANCE FROM TECHNICAL SUPPORT, THE CUSTOMER WAS UNABLE TO SUCCESSFULLY LOAD A NEW CARTRIDGE. THE ISSUE WAS ESCALATED TO ADDITIONAL SUPPORT, AND IT WAS DETERMINED THAT THE CUSTOMER NEEDED A LOANER PUMP. CUSTOMER SERVICE PROVIDED GUIDANCE ON SIGNING THE LOANER AGREEMENT AND CONFIRMED THE RETURN DATE FOR THE TEMPORARY PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003103 ↗
• MalfunctionDec 23, 2025Key or Button Unresponsive/not Working; Key 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 23879211 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140015. One submission often covers many models, so check the product and lot details in each record.

• Z-2471-2018 · Apr 23, 2018 · Open, Classified
  t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.