Crit-Line® CL10051001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840861101122), received between Jun 10, 2020 and Jan 26, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fire” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Fire

  A USER FACILITY'S DIALYSIS TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SOME TIME LAST YEAR A CLM IV MONITOR¿S POWER CORD CAUGHT FIRE. UPON FOLLOW UP, THE DIALYSIS TECHNICIAN SAID THAT THE ISSUE OCCURRED ON (B)(6) 2025. THE CRIT-LINE MONITOR (CLM) SERIAL NUMBER IS UNKNOWN. IT IS UNKNOWN WHEN THE FIRE OCCURRED. THE FIRE WAS CAUSED BY THE POWER SUPPLY. A SMOKE SMELL WAS NOTED BY AN OVERNIGHT EMPLOYEE. THE SMOKE ALARMS DID NOT GO OFF. THERE WAS NO DAMAGE TO ANY OTHER COMPONENTS AS A RESULT OF THIS ISSUE. THE CLM IS PLUGGED IN TO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE ISSUE WAS RESOLVED BY REPLACING THE POWER CORD. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE. THERE WERE NO SAMPLES AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177747 ↗
• MalfunctionJan 23, 2026Fire

  A USER FACILITY'S DIALYSIS TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A CLM IV MONITOR¿S POWER CORD CAUGHT FIRE. UPON FOLLOW UP, THE CUSTOMER SAID THAT THE ISSUE OCCURRED ON (B)(6) 2026. THE FIRE OCCURRED OVERNIGHT WHILE THE CLINIC WAS CLOSED. IT WAS DISCOVERED BY AN ENVIRONMENTAL SERVICES (EVS) EMPLOYEE AND THE FIRE WAS EXTINGUISHED. THE FIRE DID NOT TRIGGER THE FACILITY SMOKE DETECTORS. IT IS UNKNOWN IF A FIRE EXTINGUISHER WAS USED. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS ISSUE. THE CRIT LINE MONITOR (CLM) WAS PLUGGED IN TO A HOSPITAL GRADE GROUND FAULT CIRCUIT INTERRUPTER (GCFI). THERE WAS A LITTLE CHARRING ON THE CLM, BUT IT WIPED OFF. THE POWER CORD WAS REPLACED, WHICH RESOLVED THE ISSUE. THE CLM IS BACK IN SERVICE WITHOUT ANY ISSUES. THE COMPLAINT SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THREE PHOTOGRAPHS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162638 ↗
• MalfunctionJan 11, 2024Fire; Melted; Smoking; Fire; Melted; Smoking

  THE HOSPITAL SAFETY QUALITY SPECIALIST REPORTED TO FRESENIUS THAT THE CRIT-LINE CLIP (CLIC) DEVICE CAUGHT FIRE WHILE CONNECTED TO THE POWER ADAPTER OF THE CLM IV MONITOR. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED EVENT. NO PATIENTS OR INDIVIDUALS WERE HARMED. THE MACHINE WAS PLUGGED IN BUT NOT POWERED ON OR ACTIVELY IN USE WHEN THE REPORTED EVENT OCCURRED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. A NURSE RETURNED TO THE UNIT AND VISUALLY OBSERVED A SMOKING FLAME. UNPLUGGING THE MONITOR FROM THE WALL OUTLET EXTINGUISHED THE FIRE. NO SMOKE DETECTORS WITHIN THE FACILITY WERE TRIGGERED. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. IT WAS NOTED THAT THE CLIC DEVICE WAS PLUGGED INTO THE TOP PLUG OF THE BATTERY PACK AND HAD MELTED. NO ISSUES WERE FOUND WITH THE WALL OUTLET. NO REPAIRS WERE MADE TO THE PRODUCTS. THE PRODUCTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498238 ↗
• MalfunctionJun 10, 2020Thermal Decomposition of Device; Fire; Melted; Smoking; Thermal Decomposition of Device; Fire; Melted; Smoking

  THE BIOMEDICAL EQUIPMENT SPECIALIST (BIOMED) FROM A HEMODIALYSIS (HD) USER FACILITY REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A CRIT-LINE MONITOR (CLM) IV CAUGHT ON FIRE. AN HD TECHNICIAN REPORTEDLY WALKED INTO THE TREATMENT ROOM AND HEARD AN ARC (OR SPARK-LIKE) SOUND. THIS WAS IMMEDIATELY FOLLOWED BY THE CLM CATCHING ON FIRE. THE CLM WAS MOUNTED TO AN INTRAVENOUS (IV) POLE ON A B. BRAUN DIALOG+ HD MACHINE. THE MACHINE WAS NOT IN USE AT THE TIME. THE TECHNICIAN YELLED ¿FIRE¿ AND ONE OF THE NURSES IMMEDIATELY PULLED THE FIRE ALARM WHILE ANOTHER NURSE CALLED THE EMERGENCY LINE. THE TECHNICIAN BEAT THE FIRE OUT WITH A DRY TOWEL, UNPLUGGED THE POWER SUPPLY FROM THE WALL, AND THEN REMOVED THE CLM FROM THE IV POLE. THE HD TECHNICIAN WANTED TO GET THE CLM OUT OF THE ROOM BECAUSE IT WAS SMOKING AND PATIENTS WERE STILL RECEIVING TREATMENT IN THE ROOM. ONCE REMOVED FROM THE TREATMENT ROOM, A DOOR WAS OPENED TO LET FRESH AIR IN. THE HD TECHNICIAN CONTINUED TO ¿SMOTHER¿ THE AC ADAPTER AND MONITOR WITH A DRY TOWEL. THE BIOMED RESPONDED TO THE SCENE AND TOOK POSSESSION OF THE DEVICE. THE DEVICE WAS ¿DANGER TAGGED¿ AND PULLED FROM SERVICE. AS A PRECAUTION, ALL OTHER CLM¿S WERE REMOVED FRO

  Patient problems: No Patient Involvement

  MAUDE report 10138918 ↗