Hemodialysis Bloodlines SL-2010M2096ARecalls & reported problems
B. Braun Medical Inc. · STREAMLINE BLOODLINE SET FOR DIALOG DR · Class 2
All models of Hemodialysis Bloodlines (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun Streamline bloodline is dialysis tubing. Its 479 adverse event reports mostly describe air bubbles in the lines and leaks, with some mentioning bleeding. There is 1 death and no injuries. There are 2 open recalls, one for air bubbles forming in the blood tubing and one for a connector that may not fully open and could block flow.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 483
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 483 adverse event reports that list this exact device (DI 04046955674992), received between Jul 15, 2022 and Sep 29, 2026 — classified as 1 death, 482 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (293 reports).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
Recalls naming this device
- Mar 19, 2026Class IOpen, 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 ↗
- 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-3179-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device293
- Leak/Splash111
- Detachment of Device or Device Component78
- Material Puncture/Hole30
- Loose or Intermittent Connection21
- Crack11
- Device Alarm System11
- Fluid/Blood Leak8
Patient problems
- No Clinical Signs, Symptoms or Conditions414
- Hemorrhage/Blood Loss/Bleeding68
- Air Embolism1
- Low Blood Pressure/ Hypotension1
- Reduced Blood Flow1
- Skin Discoloration1
Recent adverse event reports
The 25 most recent of 483 reports, 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, 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 ↗MalfunctionMay 15, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: AT BEGINNING OF DIALYSIS, BLOOD BEGAN LEAKING FROM THE VENOUS CONNECTION POINT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25193309 ↗MalfunctionMay 15, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 4: MACRO BUBBLES CONTINUE IN LINES. CONNECTIONS CHECKED AND TIGHTENED. BUBBLES ALSO APPEARING IN THE SALINE LINE. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192893 ↗MalfunctionMay 15, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 6: MACRO BUBBLES CONTINUE IN LINES. CONNECTIONS CHECKED AND TIGHTENED. BUBBLES ALSO APPEARING IN THE SALINE LINE. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192525 ↗MalfunctionMay 15, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: MACRO BUBBLES CONTINUE IN LINES. CONNECTIONS CHECKED AND TIGHTENED. BUBBLES ALSO APPEARING IN THE SALINE LINE. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192512 ↗MalfunctionMay 15, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: MACRO BUBBLES CONTINUE IN LINES. CONNECTIONS CHECKED AND TIGHTENED. BUBBLES ALSO APPEARING IN THE SALINE LINE. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192511 ↗MalfunctionMay 15, 2026Air/Gas in Device
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192509 ↗MalfunctionMay 15, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: MACROBUBBLES NOTED IN ARTERIAL LINE AND SALINE LINE OF TUBING DURING TREATMENT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192482 ↗MalfunctionMay 15, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: MACRO BUBBLES CONTINUE IN LINES. CONNECTIONS CHECKED AND TIGHTENED. BUBBLES ALSO APPEARING IN THE SALINE LINE. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192481 ↗MalfunctionMay 15, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: MACROBUBBLES NOTED IN ARTERIAL LINE AND SALINE LINE OF TUBING DURING TREATMENT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25192479 ↗MalfunctionMay 14, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: THE BUBBLE ON THE VENOUS SIDE IS FILLING CONTINUOUSLY, WHICH CAUSES THE MACHINE TO ALARM. CUSTOMER ALSO STATED THAT THEY ARE NOTICING MICRO BUBBLES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179370 ↗MalfunctionMay 12, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: AT BEGINNING OF DIALYSIS, BLOOD BEGAN LEAKING FROM THE VENOUS CONNECTION POINT. ADDITIONALLY, PHOTOS WERE PROVIDED WHICH REVEALED THE PRESENCE OF AIR BUBBLES IN THE BLOODLINE TUBING. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25147999 ↗
Other Set, tubing, blood, with and without anti-regurgitation valve devices
- Hemodialysis Bloodlines SL-2010M2096B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve3 recalls3 deaths1,000 reports
- Hemodialysis Bloodlines SL-2000M2095DAB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death214 reports
- CombiSet 03-2722-9Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE8 deaths311 reports
- Hemodialysis Bloodlines SL-2000M2095B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall219 reports
- CombiSet 03-2522-1Fresenius Medical Care Holdings, Inc. · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve1 recall214 reports
- Cartridge Blood Set 101025Gambro Renal Products, S.A. de C.V. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE3 recalls80 reports
- Hemodialysis Bloodlines SL-2000M2095DB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall158 reports
- Hemodialysis Bloodlines SL-2000M2095LB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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