Hemodialysis Bloodlines SL-2000M2095LRecalls & reported problems
B. Braun Medical Inc. · Streamline® Bloodline Long Version FMC · 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 tubing used in hemodialysis. The FDA records hold 97 reports, with no deaths and 1 injury; most describe air in the line. There are 2 open recalls: one for small air bubbles that may build up in the arterial line, and one for an incomplete connection that may cause a blockage during rinseback. Reports rose to 21 in the last 12 months from 0 in the prior 12 months.
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
- 97
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 04046955348909), received between Mar 17, 2021 and Feb 11, 2026 — classified as 1 injury, 96 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (53 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-1801-2026 · 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-3176-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device53
- Leak/Splash26
- Material Puncture/Hole20
- Detachment of Device or Device Component9
- Contamination /Decontamination Problem1
- Device Alarm System1
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- Hemorrhage/Blood Loss/Bleeding43
- Angina1
- Coagulation Disorder1
- Diaphoresis1
- Dyspnea1
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Device Alarm System; Leak/Splash; Material Puncture/Hole
AS REPORTED BY THE MEDSUN (B)(4) REPORT: DESCRIBE THE EVENT OR PROBLEM: DURING DIALYSIS, RN RECEIVED CONTINUAL "AIR IN LINE" ALARM. BLOOD TUBING INSPECTED AND NOTED SMALL AMOUNT OF BLOOD ON PUMP. TRANSFUSION PAUSED, LINES CLAMPED AND DISCONNECTED FROM PATIENT, TUBING REMOVED FROM PUMP. UPON INSPECTION OF TUBING, A SMALL HOLE WAS NOTED IN THE TUBING THAT IS STRUNG INTO THE BLOOD PUMP ON THE FRESENIUS 2008 MACHINE. A SMALL AMOUNT OF BLOOD WAS NOT RETURNED TO THE PATIENT. NO KNOWN PATIENT HARM AT THIS TIME.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24317669 ↗MalfunctionJan 29, 2026Air/Gas in Device
ACCORDING TO THE COMPLAINANT, THERE WAS AIR IN ARTERIAL BLOOD LINE AT PATIENT CONNECTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24214715 ↗MalfunctionDec 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: AIR IN LINE WAS SEEN DURING USE FOR THE BLOODLINE TRANSFER SET.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23905760 ↗MalfunctionDec 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: AIR IN LINE WAS SEEN DURING USE FOR THE BLOODLINE TRANSFER SET.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23905658 ↗MalfunctionDec 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: AIR IN LINE WAS SEEN DURING USE FOR THE BLOODLINE TRANSFER SET.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23905653 ↗MalfunctionDec 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: AIR IN LINE WAS SEEN DURING USE FOR THE BLOODLINE TRANSFER SET.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23905652 ↗MalfunctionDec 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: AIR IN LINE WAS SEEN DURING USE FOR THE BLOODLINE TRANSFER SET.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23905651 ↗MalfunctionDec 23, 2025Air/Gas in Device; Air/Gas in Device
ACCORDING TO THE COMPLAINANT, AIR WAS OBSERVED IN THE STREAMLINE BLOODLINE SET. PATIENT BLOOD LOSS OCCURRED AS A RESULT OF THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23878039 ↗MalfunctionDec 23, 2025Air/Gas in Device; Air/Gas in Device
ACCORDING TO THE COMPLAINANT, AIR WAS OBSERVED IN THE STREAMLINE BLOODLINE SET. PATIENT BLOOD LOSS OCCURRED AS A RESULT OF THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23877919 ↗MalfunctionDec 23, 2025Air/Gas in Device; Air/Gas in Device
ACCORDING TO THE COMPLAINANT, AIR WAS OBSERVED IN THE STREAMLINE BLOODLINE SET. PATIENT BLOOD LOSS OCCURRED AS A RESULT OF THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23877668 ↗MalfunctionDec 23, 2025Air/Gas in Device; Air/Gas in Device
ACCORDING TO THE COMPLAINANT, AIR WAS OBSERVED IN THE STREAMLINE BLOODLINE SET. PATIENT BLOOD LOSS OCCURRED AS A RESULT OF THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23877620 ↗MalfunctionDec 23, 2025Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 1: HOLE IN VENOUS CHAMBER (2 SETS OF LINES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877492 ↗MalfunctionDec 23, 2025Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 2: HOLE IN VENOUS CHAMBER (2 SETS OF LINES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877490 ↗MalfunctionDec 23, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: NURSE EDUCATOR REPORTS ONGOING PRODUCT ISSUES WITH NEW LOT NUMBERS COVERING MULTIPLE CLINICS IN HER AREA WITH SIGNIFICANT IMPACTS TO PATIENT CARE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23876752 ↗MalfunctionDec 23, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: "MICRO-AIR BUBBLES OBSERVED IN THE BLOODLINE AND AIR-IN-LINE ALARMS DUE TO DAMAGED ARTERIAL AND VENOUS PATIENT CONNECTORS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876505 ↗MalfunctionDec 22, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: "MICRO-AIR BUBBLES OBSERVED IN THE BLOODLINE AND AIR-IN-LINE ALARMS DUE TO DAMAGED ARTERIAL AND VENOUS PATIENT CONNECTORS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866286 ↗MalfunctionDec 22, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: "MICRO-AIR BUBBLES OBSERVED IN THE BLOODLINE AND AIR-IN-LINE ALARMS DUE TO DAMAGED ARTERIAL AND VENOUS PATIENT CONNECTORS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866285 ↗MalfunctionDec 19, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: NURSE EDUCATOR REPORTS ONGOING PRODUCT ISSUES WITH NEW LOT NUMBERS COVERING MULTIPLE CLINICS IN HER AREA WITH SIGNIFICANT IMPACTS TO PATIENT CARE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23851709 ↗MalfunctionDec 19, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: "MICRO-AIR BUBBLES OBSERVED IN THE BLOODLINE AND AIR-IN-LINE ALARMS DUE TO DAMAGED ARTERIAL AND VENOUS PATIENT CONNECTORS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850916 ↗MalfunctionDec 9, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: MICROAIR IN BLOOD LINE. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23757178 ↗MalfunctionNov 24, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: NOTICING TREND OF LOOSE LOCK SITE WITH MICROBUBBLES IN STREAMLINE LONG BLOOD LINES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23633620 ↗MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPROTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION AS AM TX WAS BEING INITIATED. THE BLOOD TUBING SEPARATED FROM THE BOTTOM OF THE VENOUS TUBING. DETAILED INQUIRY DESCRIPTION AS AM TX WAS BEING INITIATED. THE BLOOD TUBING SEPARATED FROM THE BOTTOM OF THE VENOUS TUBING. ARTERIAL BLOOD WAS RETURNED BUT BLOOD FROM THE PUMP SEGMENT ON HAD TO BE DISCARDED SINCE THERE WAS NO WAY TO RETURN (ESTIMATED 100ML). NEW CIRCUIT SET UP AND PT HAD NO PROBLEMS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20063336 ↗MalfunctionJun 28, 2024Leak/Splash; Detachment of Device or Device Component; Air/Gas in Device; Leak/Splash; Detachment of Device or Device Component; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: THE NURSE WAS RUNNING TREATMENT WITH THE PATIENT FOR ABOUT 40MIN INTO THE TREATMENT NURSE NOTICE A DRIP OF BLOOD AT THE ATRIAL PORTION, LEAKED AT THE DIALYZER BY HEPARIN LINE WHERE THESE 2 PIECES MOLD TOGETHER, IT CAME APART. THIS COULD POSSIBLY BE CAUSING AIR INTO THE SYSTEM. SAMPLE WITH THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639180 ↗MalfunctionJun 27, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION MICROBUBBLES APPEAR IN TUBING WHILE RUNNING DETAILED INQUIRY DESCRIPTION MICROBUBBLES ARE NOTED IN ARTERIAL TUBING AFTER TX HAS BEEN GOING FOR 2-3 HRS. SOMETIMES, THEY CHANGE THE EXTRACORPOREAL CIRCUIT TO FINISH OUT THE TX. DID NOT SPECIFY THE FREQUENCY BUT STATED IT VARIES.INSTRUCTED STAFF ON THE CORRECT PROCEDURE FOR CONNECTING PATIENT-END OF BLOODLINE (MAKING SURE CONNECTION IS 'TIGHT' PRIOR TO TWISTING RED DISCONNECT PREVENTER COLLAR) AND ALSO INSTRUCTED ON PROGRADE RINSEBACK TECHNIQUE SO THAT ALL BLOOD PASSES THROUGH AIR DETECTOR DURING THE RINSEBACK (FOR SAFETY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19625994 ↗MalfunctionJun 12, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: STREAMLINES ARE LEAKING NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19518977 ↗
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
- 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
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