Hemodialysis Bloodlines SL-2000M2095DARecalls & reported problems
B. Braun Medical Inc. · STREAMLINE FRESENIUS FOR DAVITA · 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 hemodialysis bloodline set carries blood to and from the dialysis machine. Its 215 reports include 1 death and no injuries. Most reports describe air bubbles in the lines that cause problems with blood return, and many describe leaks at connection points. There are 2 open recalls, over air bubbles in the arterial line and a connector that may not fully insert, risking blockage.
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
- 214
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 04046955776023), received between Aug 24, 2023 and May 27, 2026 — classified as 1 death, 213 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (172 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-1800-2026 · 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-3175-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device172
- Leak/Splash88
- Device Alarm System25
- Detachment of Device or Device Component20
- Material Puncture/Hole7
- Crack5
- Break3
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions139
- Hemorrhage/Blood Loss/Bleeding73
- Anemia1
- Embolism/Embolus1
- Lethargy1
Recent adverse event reports
The 25 most recent of 214 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 4: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. ADDITIONALLY, THE SALINE LINE LEAKING AT CONNECTION POINT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25301422 ↗MalfunctionMay 27, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 5: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. ADDITIONALLY, THE SALINE LINE LEAKING AT CONNECTION POINT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25300792 ↗MalfunctionMay 27, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. ADDITIONALLY, THE SALINE LINE LEAKING AT CONNECTION POINT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25300790 ↗MalfunctionMay 27, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. ADDITIONALLY, THE SALINE LINE LEAKING AT CONNECTION POINT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25300789 ↗MalfunctionMay 27, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. ADDITIONALLY, THE SALINE LINE LEAKING AT CONNECTION POINT. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25300784 ↗MalfunctionMay 24, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. SALINE LINE LEAKING AT CONNECTION POINT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25266960 ↗MalfunctionMay 24, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 4: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. SALINE LINE LEAKING AT CONNECTION POINT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25266959 ↗MalfunctionMay 24, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. SALINE LINE LEAKING AT CONNECTION POINT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25266958 ↗MalfunctionMay 24, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 5: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. SALINE LINE LEAKING AT CONNECTION POINT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25266957 ↗MalfunctionMay 24, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: AIR BUBBLES IN LINES CAUSING ISSUES WITH RINSE BACK AND BLOOD RETURN. SALINE LINE LEAKING AT CONNECTION POINT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25266956 ↗MalfunctionMar 18, 2026Device Alarm System; Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICROBUBBLES FROM IV PORT THOUGH ARTERIAL AND VENOUS LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626905 ↗MalfunctionMar 18, 2026Device Alarm System; Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICROBUBBLES FROM IV PORT THOUGH ARTERIAL AND VENOUS LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625924 ↗MalfunctionMar 11, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: STREAMLINES ARE CAUSING A LOT OF AIR FLOW THROUGH THE LINES AND IT'S STOPPING THE BLOOD FROM FLOWING THROUGH. NO INJURY REPORTED.
Patient problems: Anemia
MAUDE report 24575707 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182158: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461405 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182154: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461403 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182155: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461401 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182156: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461400 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182157: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461399 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182151: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461340 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182150: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461338 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182153: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461336 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182152: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461334 ↗MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
PER MEDWATCH NUMBER MW5182149: CONTINUOUS AIR DETECTOR ALARM; LEAKING THROUGH IV PORT AND MICRO BUBBLES FROM IV PORT THOUGH ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461333 ↗MalfunctionFeb 19, 2026Device Alarm System; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: WE HAVE SEVERAL LOTS OVER THE LAST 8 WEEKS THAT HAVE HAD AIR IN THE LINE (AIR IN LINE POST NEEDLE CONNECTION TO PRE DIALYZER) THAT TRIGGERS THE MACHINE SYSTEM TO ALARM, VENOUS PRESSURE TO BECOME ERRATIC CAUSING DISRUPTION IN TREATMENT AND CLOTTING. NO INJURY REPORTED.
Patient problems: Embolism/Embolus
MAUDE report 24389223 ↗MalfunctionFeb 12, 2026Device Alarm System; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 6: END USER REPORTS SIX (6) INCIDENTS WHERE THE STREAMLINE FRESENIUS FOR DAVITA LINES WERE NOTED TO HAVE MACRO BUBBLES IN THE LINE. THE MACHINE ALARMED "AIR BUBBLE DETECTOR" DURING PATIENT TREATMENT. TREATMENT WAS STOPPED - PATIENT BLOOD LOSS OF 10 - 15 CC OF BLOOD PER PATIENT. PATIENT WAS NOT PUT BACK ON THE MACHINE AS THEY REFUSED TO CONTINUE TREATMENT. AIR BUBBLES VISUAL ON ARTERIAL AND VENOUS LINES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24323271 ↗
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-2010M2096AB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death483 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.
How reports and recalls are matched · Editorial policy · Report an error on this page