Level 1 L-370Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10695085002819), received between Sep 7, 2017 and Feb 3, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

11 other recalls cover devices cleared under the same FDA submission (K911383); 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE HOTLINE 3 RECIRCULATING FLUID WENT INTO THE PATIENT SIDE OF THE TUBING. THE DEVICE WAS BROKEN OFF AND WENT TO THE PATIENT. THERE WAS NO EXTERNAL LEAKING. THERE WAS PATIENT INVOLVEMENT, AND THERE WAS NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250309 ↗
• MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT DEVICE HOTLINE LEAKED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936647 ↗
• InjuryAug 25, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING SURGERY, A CAROTID ENDARTERECTOMY WAS CANCELLED SECONDARY TO A DISPOSABLE HOTLINE TUBING DEFECT THAT LED TO POSSIBLE DELIVERY OF WARMING WATER THROUGH THE IV TUBING INSTEAD OF BLOOD INTO THE PATIENT. PER REPORTER, THE WARMING WATER USED IN THE HOTLINE BLOOD WARMING DEVICE WAS NOT STERILE AND THIS BEING INJECTED INTO THE PATIENT'S BLOOD STREAM DUE TO THE TUBING DEFECT, WHICH IS LIFE THREATENING. REPORTER STATED THE TUBING HAD A DEFECT WHERE-IN RATHER THAN DELIVERING THE WARMED BLOOD, IT WAS DELIVERING THE FLUID/WATER BEING USED TO WARM THE BLOOD. THE SURGICAL CASE WAS ABORTED IMMEDIATELY.

  Patient problems: Insufficient Information

  MAUDE report 22889122 ↗
• MalfunctionDec 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE PRODUCT WAS BEING USED, FLUID WAS LEAKING. STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS UNKNOWN. THERE WAS UNKNOWN PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT WAS BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028757 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HOTLINE FLUID TUBING WAS LEAKING AT THE CONNECTION POINT BETWEEN THE TWO LOCKING TABS AND THE SOCKET. TO ENSURE IT WAS NOT A PROBLEM WITH THE BLOOD WARMING MACHINE, THE NURSES TRIED TWO ADDITIONAL MACHINES, BUT THE LEAK PERSISTED. HOWEVER, WHEN THEY SWITCHED TO A NEW TUBING SET, THE ISSUE WAS RESOLVED, INDICATING THAT THE ORIGINAL SET WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481706 ↗
• MalfunctionOct 31, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A BENCH TEST, THERE WERE AIR BUBBLES NOTED IN THE TUBING. THERE WAS NO PATIENT INJURY. DEVICE PULLED FROM USE. EVENT REPORTED AS "STILL ON GOING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039381 ↗
• MalfunctionOct 11, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A BENCH TEST, AIR BUBBLES WERE NOTED IN HOTLINE TUBING. NO INJURY OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912039 ↗
• MalfunctionOct 11, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A BENCH TEST, AIR BUBBLES WERE NOTED IN HOTLINE TUBING. NO INJURY OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911850 ↗
• MalfunctionOct 10, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A BENCH TEST, AIR BUBBLES WERE NOTED IN HOTLINE TUBING. NO INJURY OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905715 ↗
• MalfunctionNov 18, 2022Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  ADDITIONAL INFORMATION RECEIVED ON 09-DEC-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: THE CUSTOMER REPORTED THAT WE NEED TO DISREGARD THIS ISSUE. THEY FOUND FROM THE TECHNICAL DEPARTMENT THAT THEY NEED TO MAKE SURE TO PUSH IN THE LINE ALL THE WAY AND THIS WAS VERY DIFFICULT TO DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829304 ↗
• MalfunctionNov 18, 2022Difficult to Insert; Leak/Splash; Connection Problem; Difficult to Insert; Leak/Splash; Connection Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE CONNECTION NOT BEING COMPLETELY CONNECTED. THE UNIT WAS LEAKING FLUID DUE TO THE NEW TUBING. THIS HAS BEEN HAPPENING OFTEN WITH THE NEW SYSTEM. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828826 ↗
• MalfunctionNov 18, 2022Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE CONNECTION NOT BEING COMPLETELY CONNECTED. THE UNIT WAS LEAKING FLUID DUE TO THE NEW TUBING. THIS HAS BEEN HAPPENING OFTEN WITH THE NEW SYSTEM. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828656 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE ROUTINELY EXPERIENCED THE CONNECTIVE TUBING (@ TOP OF THE L-370 SETS) KINKING OFF, WHEN ATTACHED TO EITHER AN IV ADMIN. SET OR BLOOD SET, IN MULTIPLE AREAS. MULTIPLE OCCASIONS, SINCE BEGAN USING HL-390 AND L-370 OVER LAST FEW MONTHS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699677 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE ROUTINELY EXPERIENCED THE CONNECTIVE TUBING (@ TOP OF THE L-370 SETS) KINKING OFF, WHEN ATTACHED TO EITHER AN IV ADMIN. SET OR BLOOD SET, IN MULTIPLE AREAS. MULTIPLE OCCASIONS, SINCE BEGAN USING HL-390 AND L-370 OVER LAST FEW MONTHS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698599 ↗
• MalfunctionOct 28, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE ROUTINELY EXPERIENCED THE CONNECTIVE TUBING (AT THE TOP OF THE SETS) KINKING OFF, WHEN ATTACHED TO EITHER AN INTRAVENOUS THERAPY (IV) ADMINISTRATION SET OR BLOOD SET, IN MULTIPLE AREAS. THIS ISSUE HAS OCCURRED ON MULTIPLE OCCASIONS, SINCE BEGINNING USE OF THE SETS OVER LAST FEW MONTHS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692896 ↗
• MalfunctionOct 28, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE ROUTINELY EXPERIENCED THE CONNECTIVE TUBING (AT THE TOP OF THE SETS) KINKING OFF, WHEN ATTACHED TO EITHER AN INTRAVENOUS THERAPY (IV) ADMINISTRATION SET OR BLOOD SET, IN MULTIPLE AREAS. THIS ISSUE HAS OCCURRED ON MULTIPLE OCCASIONS, SINCE BEGINNING USE OF THE SETS OVER LAST FEW MONTHS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692124 ↗
• MalfunctionOct 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE ROUTINELY EXPERIENCED THE CONNECTIVE TUBING (@ TOP OF THE L-370 SETS) KINKING OFF, WHEN ATTACHED TO EITHER AN IV ADMIN. SET OR BLOOD SET, IN MULTIPLE AREAS. MULTIPLE OCCASIONS, SINCE BEGAN USING HL-390 AND L-370 OVER LAST FEW MONTHS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649924 ↗
• MalfunctionOct 21, 2022Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE PHYSICIAN HAD TO SQUEEZE THE BULB ON THE BLOOD TUBING TO MAKE THE BLOOD INFUSE FASTER. THE CONNECTION LINE BECAME CRIMPED MAKING IT DIFFICULT TO INFUSE A BOLUS OF BLOOD TO THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649919 ↗
• MalfunctionOct 20, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE ROUTINELY EXPERIENCED THE CONNECTIVE TUBING (@ TOP OF THE L-370 SETS) KINKING OFF, WHEN ATTACHED TO EITHER AN IV ADMIN. SET OR BLOOD SET, IN MULTIPLE AREAS. MULTIPLE OCCASIONS, SINCE BEGAN USING HL-390 AND L-370 OVER LAST FEW MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638368 ↗
• MalfunctionFeb 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A DURING A CRANIECTOMY,VENTRICULOSTOMY CASE THE CRNA NOTICED THAT THE STERILE WATER IN THE FLUID WARMER CONTAINER LOOKED BLOOD TINGED, THE RESULT OF SOME BACKED UP BLOOD IN THE IV TUBING. THE FLUID WARMER DEVICE AND TUBING WERE DISCONNECTED FROM THE PATIENT AND EXAMINED. IT APPEARED THAT THE FLUID WARMER TUBING WAS DEFECTIVE AND ALLOWED MIXTURE OF THE STERILE WATER FROM THE WARMER WITH THE PATIENT'S IV FLUID. THIS WAS CONFIRMED BY CONNECTING A NEW SET TO THE FLUID WARMER AND NOT ENCOUNTERING THE SAME ISSUE. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518700 ↗
• MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A LEVEL 1 HOTLINE DISPOSABLE. IT WAS REPORTED THAT THE INNER TUBE OF THE DEVICE WAS LEAKING, THE WARMER ITSELF DID NOT MALFUNCTION. HOWEVER, DURING THE CUSTOMER'S EVALUATION, THEY FOUND THAT THE WATER TANK WAS CRACKED. THE PATIENT WAS NO HAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730086 ↗
• MalfunctionNov 26, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SMITHS MEDICAL HOTLINE TUBING OBSERVED WITH KINKS. IT WAS NOTED THESE ARE KINKED WITHIN THE PACKAGING. AT LEAST ONE INSTANCE WAS WHILE IN USE WITH A PATIENT. THE FLUID WOULD NOT RUN BECAUSE OF IT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10912736 ↗
• MalfunctionNov 26, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ADDITIONAL EVENT INFORMATION: REPORTER STATED THE TUBING WAS BLOCKED AND FLUID WOULD NOT RUN. DEVICE WAS NOT USED WITH PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10912735 ↗
• InjurySep 7, 2017Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE, THE INNER TUBING OF A LEVEL 1® HOTLINE® 3 BLOOD AND FLUID WARMER WAS DEFECTIVE AND LITTLE TO NO FLUID FLOWED THROUGH THE INNER TUBING. THE EVENT OUTCOME WAS REPORTED AS "OTHER SERIOUS (IMPORTANT MEDICAL EVENT)", BUT NO INFORMATION ON THE MEDICAL EVENT WAS PROVIDED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Information

  MAUDE report 6848250 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K911383. One submission often covers many models, so check the product and lot details in each record.

• Z-2759-2026 · Jun 24, 2026 · Open, Classified
  Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperature
• Z-1443-2014 · Mar 17, 2014 · Terminated
  Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditio
• Z-1444-2014 · Mar 17, 2014 · Terminated
  Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity condit
• Z-1979-2012 · Jun 27, 2012 · Terminated
  Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in
• Z-0428-2012 · Nov 21, 2011 · Terminated
  Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjuncti
• Z-0426-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE R
• Z-0425-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE
• Z-0424-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE
• Z-0422-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE R
• Z-0423-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE
• Z-0427-2012 · Nov 21, 2011 · Terminated
  Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunctio