Hemodialysis Bloodlines SL-2010M2096Recalls & reported problems
B. Braun Medical Inc. · Streamline® Bloodline Set for Dialog+® Hemodialysis System · Class 2
All models of Hemodialysis Bloodlines (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 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 with a Dialog+ hemodialysis machine to carry blood to and from the patient. The 1,000 reports mostly describe air bubbles in the tubing, leaks, and tubing coming loose. Reports include 3 deaths and 2 injuries. Reports fell from 534 in the prior 12 months to 246 in the last 12. 3 recalls are open, covering tiny air bubbles forming in the line, damaged connectors, and incomplete connection that 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
- 1,000
- Deaths reported
- 3
- Injuries reported
- 2
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1,000 adverse event reports that list this exact device (DI 04046964367786), received between Dec 4, 2020 and May 20, 2026 — classified as 3 deaths, 2 injuries, 995 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (804 reports).
3 FDA recall records name this device's identifier, 3 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-1799-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 30, 2025Class IOpen, 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 ↗
- 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-3178-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device804
- Leak/Splash278
- Detachment of Device or Device Component51
- Contamination /Decontamination Problem21
- Device Alarm System21
- Loose or Intermittent Connection21
- Material Puncture/Hole17
- Degraded10
Patient problems
- No Clinical Signs, Symptoms or Conditions855
- Hemorrhage/Blood Loss/Bleeding142
- Insufficient Information2
- Cardiac Arrest1
- Chest Pain1
- Dyspnea1
- Lethargy1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 1,000 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MICROBUBBLES IN 5 CASES REPORTED BY STAFF TO CHRIS MATALA IN THE COURSE OF 6 WEEKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233628 ↗MalfunctionMay 20, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BUBBLES IN TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233032 ↗MalfunctionMay 20, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BUBBLES IN TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232968 ↗MalfunctionMay 20, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BUBBLES IN TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232966 ↗MalfunctionMay 11, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MICRO BUBBLES IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25141754 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: MACROBUBBLES OBSERVED IN THE ARTERIAL LINE. 3 SETS OF TUBING HAD APPROXIMATELY AN INCH OF AIR IN THE VENOUS CHAMBER BY END OF TREATMENT. 1 SET OF TUBING NEEDED TO MANUALLY BE HELD TO THE SALINE LINE DURING RINSEBACK AS IT KEPT UNSCREWING ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110842 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: MACROBUBBLES OBSERVED IN THE ARTERIAL LINE. 3 SETS OF TUBING HAD APPROXIMATELY AN INCH OF AIR IN THE VENOUS CHAMBER BY END OF TREATMENT. 1 SET OF TUBING NEEDED TO MANUALLY BE HELD TO THE SALINE LINE DURING RINSEBACK AS IT KEPT UNSCREWING ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110841 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: MACROBUBBLES OBSERVED IN THE ARTERIAL LINE. 3 SETS OF TUBING HAD APPROXIMATELY AN INCH OF AIR IN THE VENOUS CHAMBER BY END OF TREATMENT. 1 SET OF TUBING NEEDED TO MANUALLY BE HELD TO THE SALINE LINE DURING RINSEBACK AS IT KEPT UNSCREWING ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110840 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2. MACROBUBBLES OBSERVED IN THE ARTERIAL LINE UP TO THE ARTERIAL BULB. 2 SETS OF TUBING THE VENOUS CHAMBER NOTED TO HAVE APPOXIMATELY 1 INCH OF AIR ACCUMULATION. ALL PATIENTS ABLE TO COMPLETE TREATMENT AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110774 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: MACROBUBBLES OBSERVED IN THE ARTERIAL LINE UP TO THE ARTERIAL BULB. 2 SETS OF TUBING THE VENOUS CHAMBER NOTED TO HAVE APPROXIMATELY 1 INCH OF AIR ACCUMULATION. ALL PATIENTS ABLE TO COMPLETE TREATMENT AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110773 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES OBSERVED IN THE ARTERIAL LINE. TREATMENTS COMPLETED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110692 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MICROBUBBLES IN TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110639 ↗MalfunctionMay 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES IN ARTERIAL TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110632 ↗MalfunctionMay 7, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: BLOOD LEAKING FROM UNDER THE ARTERIAL POD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110604 ↗MalfunctionMay 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BUBBLES CAUSING SAFETY ALARM ON DIALYSIS MACHINE. CONNECTIONS ALL VERIFIED AND BUBBLES REMOVED FROM DIALYSIS LINES AND TREATMENT RESUMED. BUBBLE RETURNED AND SAFETY ALARM RETURNED. CAP APPLIED TO ARTERIAL MEDICATION PORT, BUBBLES REMOVED, AND TREATMENT RESUMED AGAIN. PATIENT THEN BECAME SYMPTOMATIC, BUBBLES AGAIN NOTED. PATIENT SYMPTOMS MANAGED, AND DUE TO WORRY OF BUBBLES RETURNING AND QUESTIONING IF THERE WAS A CRACK IN THE TUBING, PATIENT BLOOD NOT RETURNED. TREATMENT NOT CONTINUED FOR PATIENT WITH THIS SPECIFIC TUBING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25100327 ↗MalfunctionMay 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES NOTED IN THE ARTERIAL LINE. VENOUS CHAMBERS FILLING WITH APPROXIMATELY AN INCH OF AIR AFTER STARTING TREATMENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25094082 ↗MalfunctionApr 30, 2026Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: A FEW OF THE LINES HAD HOLES IN THE LINE WHERE THE ARTERIAL AND SALINE WERE CONNECTED THERE WAS HOLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043707 ↗MalfunctionApr 30, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES WERE OBSERVED IN THE ARTERIAL LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043378 ↗MalfunctionApr 30, 2026Device Alarm System; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES OBSERVED IN ARTERIAL LINE ONLY ON 3/4 BLOODLINES. 1 OF THE 4 BLOODLINES HAD MACROBUBBLES IN THE VENOUS LINE AND SAD ALARMS. DUE TO THE SIGNIFICANT BUBBLES IN THE VENOUS LINE AND THE SAD ALARMS, UNABLE TO RETURN PATIENT'S BLOOD.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25043228 ↗MalfunctionApr 30, 2026Device Alarm System; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES OBSERVED IN ARTERIAL LINE ONLY ON 3/4 BLOODLINES. 1 OF THE 4 BLOODLINES HAD MACROBUBBLES IN THE VENOUS LINE AND SAD ALARMS. DUE TO THE SIGNIFICANT BUBBLES IN THE VENOUS LINE AND THE SAD ALARMS, UNABLE TO RETURN PATIENT'S BLOOD.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25043224 ↗MalfunctionApr 30, 2026Device Alarm System; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES OBSERVED IN ARTERIAL LINE ONLY ON 3/4 BLOODLINES. 1 OF THE 4 BLOODLINES HAD MACROBUBBLES IN THE VENOUS LINE AND SAD ALARMS. DUE TO THE SIGNIFICANT BUBBLES IN THE VENOUS LINE AND THE SAD ALARMS, UNABLE TO RETURN PATIENTS BLOOD.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25043223 ↗MalfunctionApr 30, 2026Device Alarm System; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES OBSERVED IN ARTERIAL LINE ONLY ON 3/4 BLOODLINES. 1 OF THE 4 BLOODLINES HAD MACROBUBBLES IN THE VENOUS LINE AND SAD ALARMS. DUE TO THE SIGNIFICANT BUBBLES IN THE VENOUS LINE AND THE SAD ALARMS, UNABLE TO RETURN PATIENTS BLOOD.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25043222 ↗MalfunctionApr 29, 2026Obstruction of Flow; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MACROBUBBLES SEEN IN THE VENOUS LINE IN 8 SETS OF TUBING. 3 VENOUS CHAMBERS NOTED TO BE FILLED WITH APPROXIMATELY 1 INCH OF AIR. 1 SET OF TUBING-VENOUS BULB WAS DEFECTIVE AND FOUND TO BE OCCLUDED UNABLE TO USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035311 ↗MalfunctionApr 22, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MICROBUBBLES IN THE STREAMLINE BLOODLINE SET FOR DIALOG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954629 ↗MalfunctionApr 22, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MICROBUBBLES IN THE STREAMLINE BLOODLINE SET FOR DIALOG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954628 ↗
Other Set, tubing, blood, with and without anti-regurgitation valve devices
- 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
- 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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