Hemodialysis Bloodlines SL-2000M2095Recalls & reported problems

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 04046964367762), received between Dec 22, 2020 and Jan 20, 2026 — classified as 219 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (82 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 15, 2024Class IIOpen, Classified

   Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method

   Z-3173-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 219 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: THE SALINE LINE - WHEN ATTACHED, IT LEAKED. SOME LET AIR THROUGH. WAS THERE PATIENT INJURY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121087 ↗
• MalfunctionDec 3, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED WHEN THEY GO TO RETURN THE PATIENT, THE CONNECTION AT THE SALINE LINE AND THE ATRIAL LINE, THEY TWIST IT AND IT SEALS CORRECT BUT THE LINE GETS A WHOLE BUNCH OF AIR MORE THAN MICRO BUBBLES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705624 ↗
• MalfunctionDec 3, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED WHEN THEY GO TO RETURN THE PATIENT, THE CONNECTION AT THE SALINE LINE AND THE ATRIAL LINE, THEY TWIST IT AND IT SEALS CORRECT BUT THE LINE GETS A WHOLE BUNCH OF AIR MORE THAN MICRO BUBBLES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705604 ↗
• MalfunctionDec 3, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED WHEN THEY GO TO RETURN THE PATIENT, THE CONNECTION AT THE SALINE LINE AND THE ATRIAL LINE, THEY TWIST IT AND IT SEALS CORRECT BUT THE LINE GETS A WHOLE BUNCH OF AIR MORE THAN MICRO BUBBLES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704739 ↗
• MalfunctionDec 3, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED WHEN THEY GO TO RETURN THE PATIENT, THE CONNECTION AT THE SALINE LINE AND THE ATRIAL LINE, THEY TWIST IT AND IT SEALS CORRECT BUT THE LINE GETS A WHOLE BUNCH OF AIR MORE THAN MICRO BUBBLES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704679 ↗
• MalfunctionDec 3, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED WHEN THEY GO TO RETURN THE PATIENT, THE CONNECTION AT THE SALINE LINE AND THE ATRIAL LINE, THEY TWIST IT AND IT SEALS CORRECT BUT THE LINE GETS A WHOLE BUNCH OF AIR MORE THAN MICRO BUBBLES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704200 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: OUR TEAMMATES EXPERIENCED LEAKAGE TWICE COMING FROM THE TWIST CAP CONNECTING THE SALINE LINE TO THE MAIN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641436 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1; CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: OUR TEAMMATES EXPERIENCED LEAKAGE TWICE COMING FROM THE TWIST CAP CONNECTING THE SALINE LINE TO THE MAIN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641435 ↗
• MalfunctionJan 30, 2025Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: SALINE LINE GOING INTO THE ATRIAL POD WILL NOT THREAD ON VERY WELL AND STARTS SLOWLY LEAKING. ALOT OF BUBBLES SHOW IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277276 ↗
• MalfunctionJan 22, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION RUPTURED DIAPHRAGM IN STREAMLINE ARTERIAL POD. DETAILED INQUIRY DESCRIPTION: APPROXIMATELY 1.5 HOURS INTO THE TREATMENT, PATIENT WAS TAKEN OFF THE MACHINE FOR A BATHROOM BREAK. WHILE RETURNING BLOOD, PCT NOTICED BLOOD IN THE ARTERIAL PRESSURE MONITORING LINE, PASSED THE DIAPHRAGM. THE MACHINE WAS REMOVED FROM USE FOR DISINFECTION. TREATMENT WAS RE-STARTED ON A DIFFERENT MACHINE WITH THE NEW SYSTEM. NO SIGNIFICANT BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206869 ↗
• MalfunctionDec 11, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: ISSUE #3: 2 BLOODLINE LETTING AIR IN THE SYSTEM WHICH MAKES PULLING SALINE THROUGH BLOODLINES VERY SLOW. QTY: 2 SAMPLE: NO. LOT #: A2400097. INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901550 ↗
• MalfunctionDec 11, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1 ISSUE #3: 2 BLOODLINE LETTING AIR IN THE SYSTEM WHICH MAKES PULLING SALINE THROUGH BLOODLINES VERY SLOW QTY: 2 SAMPLE: NO LOT #: A2400097 INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901548 ↗
• MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: ISSUE #1: SALINE LINE COMPLETELY DETACHED FROM BLOODLINE, QTY: (B)(4) EA, SAMPLE: YES, LOT#: A2400097.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901494 ↗
• MalfunctionNov 26, 2024Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED BY THE USER FACILITY: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: PIN HOLES IN THE BLOOD LINE. ALSO, THE SALINE LINE THAT CONNECTS TO THE ARTERIAL PORT IS NOT A PROPER FIT, IT WAS NOT A SECURE FIT. DATE OF INCIDENT BEING REPORTED = (B)(6) 2024. WAS THERE PATIENT INJURY? = NO. IF YES, ESTIMATED BLOOD LOSS? = NO. WAS THE PRODUCT INVOLVED SAVED? = NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786280 ↗
• MalfunctionOct 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BROKEN ARTERIAL POD. DETAILED INQUIRY DESCRIPTION: THE BASE OF THE ARTERIAL POD (WHERE THE TUBING GOES ONTO THE PLASTIC PART) HAS BROKEN OFF DURING SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513529 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 4. BRIEF INQUIRY DESCRIPTION: AIR IN LINE. DETAILED INQUIRY DESCRIPTION: WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS (DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20454939 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIR IN LINE. DETAILED INQUIRY DESCRIPTION: WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS ( DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20454187 ↗
• MalfunctionOct 15, 2024Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: WE HAVE HAD SEVERAL LINES FROM LOT A2400392 THAT SEEM TO BE HAVING ISSUES WITH AIR GETTING INTO THE ARTERIAL CHAMBER CAUSING MACHINE ALARMS AND CONTINUOUS TREATMENT INTERRUPTIONS. PLEASE LET ME KNOW HOW WE CAN GET SUPPORT TO REMEDY THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454049 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 7 BRIEF INQUIRY DESCRIPTION AIR IN LINE DETAILED INQUIRY DESCRIPTION WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS ( DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20453546 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 6. BRIEF INQUIRY DESCRIPTION: AIR IN LINE. DETAILED INQUIRY DESCRIPTION: WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS ( DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20453305 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 3. BRIEF INQUIRY DESCRIPTION: AIR IN LINE. DETAILED INQUIRY DESCRIPTION: WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS ( DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20453292 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 5. BRIEF INQUIRY DESCRIPTION: AIR IN LINE. DETAILED INQUIRY DESCRIPTION: WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS (DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20453221 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1 BRIEF INQUIRY DESCRIPTION AIR IN LINE DETAILED INQUIRY DESCRIPTION WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS ( DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20453142 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 8 BRIEF INQUIRY DESCRIPTION AIR IN LINE DETAILED INQUIRY DESCRIPTION WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS ( DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20453136 ↗
• MalfunctionOct 15, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION AIR IN LINE DETAILED INQUIRY DESCRIPTION WHILE TREATMENT WAS IN PROGRESS, THE NURSES NOTICED AIR BUBBLES IN THE ARTERIAL LINE, AS WELL AS SIGNIFICANT AMOUNT OF AIR IN THE VENOUS CHAMBER, WHICH TRIGGERED "AIR DETECTOR" ALARM. THE AMOUNT OF AIR WAS SIGNIFICANT ENOUGH THAT THE ALARM COULD NOT BE CLEARED BY THE NORMAL TROUBLESHOOTING STEPS ( DECREASE BFR, PULL AIR FROM THE VENOUS CHAMBER WITH A SYRINGE, ETC.). THEY HAD TO REMOVE THE DEFECTIVE LINES AND SET UP A NEW SYSTEM TO CONTINUE THE TREATMENT. OVER THE LAST FEW DAYS, THEY HAD 8 INSTANCES WHEN THEY WERE UNABLE TO RETURN BLOOD. APPROXIMATE BLOOD LOSS/PATIENT -250 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20453115 ↗