Hemodialysis BloodlinesRecalls & reported problems across all models

We found 9 models of Hemodialysis Bloodlines by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 2,179 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2020 and Sep 29, 2026 — classified as 5 deaths, 6 injuries, 2,168 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1,468 reports).

14 FDA recall records name at least one of these models by its device identifier, 14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Hemodialysis Bloodlines recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 19, 2026Open, Classified

   Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

   Z-1803-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 19, 2026Open, Classified

   Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

   Z-1802-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 19, 2026Open, Classified

   Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

   Z-1801-2026 · Root cause: Device Design · Recall details · FDA record ↗

4. Mar 19, 2026Open, Classified

   Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

   Z-1800-2026 · Root cause: Device Design · Recall details · FDA record ↗

5. Mar 19, 2026Open, Classified

   Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

   Z-1799-2026 · Root cause: Device Design · Recall details · FDA record ↗

6. Mar 19, 2026Open, Classified

   Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

   Z-1798-2026 · Root cause: Device Design · Recall details · FDA record ↗

7. Sep 30, 2025Open, Classified

   The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

   Z-0070-2026 · Root cause: Process control · Recall details · FDA record ↗

8. Aug 15, 2024Open, 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-3179-2024 · Root cause: Device Design · Recall details · FDA record ↗

9. Aug 15, 2024Open, 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-3178-2024 · Root cause: Device Design · Recall details · FDA record ↗

10. Aug 15, 2024Open, 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-3177-2024 · Root cause: Device Design · Recall details · FDA record ↗

11. Aug 15, 2024Open, 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-3176-2024 · Root cause: Device Design · Recall details · FDA record ↗

12. Aug 15, 2024Open, 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-3175-2024 · Root cause: Device Design · Recall details · FDA record ↗

13. Aug 15, 2024Open, 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-3174-2024 · Root cause: Device Design · Recall details · FDA record ↗

14. Aug 15, 2024Open, 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 Hemodialysis Bloodlines problems

Hemodialysis Bloodlines models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Hemodialysis Bloodlines SL-2010M2096

  Set, tubing, blood, with and without anti-regurgitation valve
  3 recalls3 deaths1,000 reports
• Hemodialysis Bloodlines SL-2010M2096A

  Set, tubing, blood, with and without anti-regurgitation valve
  2 recalls1 death483 reports
• Hemodialysis Bloodlines SL-2000M2095DA

  Set, tubing, blood, with and without anti-regurgitation valve
  2 recalls1 death214 reports
• Hemodialysis Bloodlines SL-2000M2095

  Set, tubing, blood, with and without anti-regurgitation valve
  1 recall219 reports
• Hemodialysis Bloodlines SL-2000M2095D

  Set, tubing, blood, with and without anti-regurgitation valve
  1 recall158 reports
• Hemodialysis Bloodlines SL-2000M2095L

  Set, tubing, blood, with and without anti-regurgitation valve
  2 recalls97 reports
• Hemodialysis Bloodlines B3-4630M4705

  Set, tubing, blood, with and without anti-regurgitation valve
  1 recall5 reports
• Hemodialysis Bloodlines B3-3632M3705

  Set, tubing, blood, with and without anti-regurgitation valve
  1 recall2 reports
• Hemodialysis Bloodlines SL-2000M2095W

  Set, tubing, blood, with and without anti-regurgitation valve
  1 recall1 report

Recent Hemodialysis Bloodlines adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927919 ↗
• MalfunctionSep 29, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927915 ↗
• MalfunctionSep 29, 2026Difficult to Remove

  As reported by the user facility:Event 1:Multiple incidents (at least 6) where the venous locking ring threads are slightly mismatched or not aligned correctly for connecting the inlet set to dialysis catheter. This makes it extremely difficult to screw and disconnect the venous line from the catheter lumen at end of treatment. In one case, a patient's catheter lumen was cracked/piece chipped off because the tech used a lot of force.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927908 ↗
• MalfunctionSep 29, 2026Difficult to Remove

  As reported by the user facility:Event 4:Multiple incidents (at least 6) where the venous locking ring threads are slightly mismatched or not aligned correctly for connecting the inlet set to dialysis catheter. This makes it extremely difficult to screw and disconnect the venous line from the catheter lumen at end of treatment. In one case, a patient's catheter lumen was cracked/piece chipped off because the tech used a lot of force.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927905 ↗
• MalfunctionSep 29, 2026Difficult to Remove

  As reported by the user facility:Event 5:Multiple incidents (at least 6) where the venous locking ring threads are slightly mismatched or not aligned correctly for connecting the inlet set to dialysis catheter. This makes it extremely difficult to screw and disconnect the venous line from the catheter lumen at end of treatment. In one case, a patient's catheter lumen was cracked/piece chipped off because the tech used a lot of force.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927901 ↗
• MalfunctionSep 29, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927894 ↗
• MalfunctionSep 15, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777881 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611603 ↗
• MalfunctionJun 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BUBBLES IN THE ARTERIAL LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461664 ↗
• MalfunctionJun 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MACRO BUBBLES CONTINUE IN LINES. CONNECTIONS CHECKED AND TIGHTENED. BUBBLES ALSO APPEARING IN THE SALINE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456973 ↗
• MalfunctionJun 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MACROBUBBLES NOTED IN ARTERIAL LINE AND SALINE LINE OF TUBING DURING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456441 ↗
• MalfunctionJun 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MACROBUBBLES LOCATED AT THE SALINE TO BLOODLINE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456385 ↗
• MalfunctionJun 8, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: ARTERIAL LINE CRACKED AND LEAKING BLOOD. WAS CRACKED RIGHT WHERE CONNECT TO FILTER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25428867 ↗
• MalfunctionJun 8, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: INFORMING YOUR DEPARTMENT THAT OUR NURSES CAUGHT A LEAK WHILE THE FOLLOWING BLOODLINE WAS USED DURING A HEMODIALYSIS TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428830 ↗
• MalfunctionJun 8, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MACROBUBBLES PRESENT AT THE SALINE LINE BLOODLINE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428786 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls
• Caresite23 models · 420 reports · 4 recalls