Level 1 FC400-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10695085000501), received between Jul 26, 2017 and Jan 22, 2021 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 reports).

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 16, 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.

• InjuryJan 22, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL TEMPERATURE PROBES/LEVEL 1 FOLEY CATHETERS WAS CLOGGED. THE AFFECTED LOT NUMBERS WERE PROVIDED. THE PATIENT ENDURED DISCOMFORT AS BACTERIAL CONTAMINATION OCCURRED REQUIRING TREATMENT AND LONGER STAY IN HOSPITAL. ULTRASOUND SCAN WAS PERFORMED FOR CATHETER REINSERTION. PATIENT INFORMATION ON COVER PAGE.

  Patient problems: Pain

  MAUDE report 11218912 ↗
• InjuryJan 22, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL TEMPERATURE PROBES/LEVEL 1 FOLEY CATHETERS WAS CLOGGED. THE AFFECTED LOT NUMBERS WERE PROVIDED. THE PATIENT ENDURED DISCOMFORT AS BACTERIAL CONTAMINATION OCCURRED ,REQUIRING TREATMENT AND LONGER STAY IN HOSPITAL. ULTRASOUND SCAN WAS PERFORMED FOR CATHETER REINSERTION. PATIENT INFORMATION ON COVER PAGE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 11218895 ↗
• InjuryJan 22, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL TEMPERATURE PROBES/LEVEL 1 FOLEY CATHETERS WAS CLOGGED. THE AFFECTED LOT NUMBERS WERE PROVIDED. THE PATIENT ENDURED DISCOMFORT AS BACTERIAL CONTAMINATION OCCURRED REQUIRING TREATMENT AND LONGER STAY IN HOSPITAL. ULTRASOUND SCAN WAS PERFORMED FOR CATHETER REINSERTION. PATIENT INFORMATION ON COVER PAGE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 11218472 ↗
• InjuryJan 22, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL TEMPERATURE PROBES/LEVEL 1 FOLEY CATHETERS WAS CLOGGED. THE AFFECTED LOT NUMBERS WERE PROVIDED. THE PATIENT ENDURED DISCOMFORT AS BACTERIAL CONTAMINATION OCCURRED REQUIRING TREATMENT AND LONGER STAY IN HOSPITAL. ULTRASOUND SCAN WAS PERFORMED FOR CATHETER REINSERTION. PATIENT INFORMATION ON COVER PAGE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 11217776 ↗
• MalfunctionJan 20, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL TEMPERATURE PROBES/LEVEL 1 FOLEY CATHETERS WAS CLOGGED. THE AFFECTED LOT NUMBERS WERE PROVIDED. THE PATIENT ENDURED DISCOMFORT AS BACTERIAL CONTAMINATION OCCURRED REQUIRING TREATMENT AND LONGER STAY IN HOSPITAL. ULTRASOUND SCAN WAS PERFORMED FOR CATHETER REINSERTION. PATIENT INFORMATION ON COVER PAGE.

  Patient problems: Abdominal Pain

  MAUDE report 11202905 ↗
• MalfunctionJan 19, 2021Complete Blockage; Complete Blockage

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CATHETER WAS CLOGGED. THIS ISSUE HAPPENED AT LEAST 5 TIMES DURING THE LAST THREE WEEKS. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Information

  MAUDE report 11194522 ↗
• InjuryAug 18, 2017Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT DURING USE OF THIS LEVEL 1® TEMPERATURE-SENSING FOLEY CATHETER, THE TEMPERATURE DISPLAY WAS INACCURATE, CAUSING DELAY IN TREATMENT FOR INFECTION AND HYPOTHERMIA. THE CATHETER HAD BEEN IN USE APPROXIMATELY 15 DAYS PRIOR TO THIS ISSUE. THE READING MEASURED 36.1° WHEREAS THE CENTRAL CATHETER MEASURED 38.6°. MEDICAL TREATMENT WAS PRESCRIBED, AND THE INFECTION AND HYPOTHERMIA RESOLVED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6804980 ↗
• InjuryJul 26, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF A LEVEL 1® FOLEY CATHETER TEMPERATURE SENSOR BURST UPON INSPECTION IN THE PATIENT'S BLADDER. THE CATHETER AND BALLOON PIECES WERE REMOVED. ALL PIECES OF THE BALLOON WERE ACCOUNTED FOR. NO PERMANENT INJURY WAS REPORTED, AND THE EVENT OUTCOME WAS REPORTED AS RESOLVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6744939 ↗