Hemodialysis Bloodlines SL-2000M2095DRecalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun hemodialysis bloodline is tubing that carries blood during dialysis treatment. Many reports describe air getting into the lines, leaks, and holes in the tubing, and some describe parts coming apart. The 158 reports include no deaths and no injuries. One open recall, begun in August 2024, concerns a patient connector that may not fully insert, which could block flow when blood is returned to the patient.
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
- 158
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 04046955348763), received between Jun 11, 2021 and Jan 9, 2024 — classified as 158 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (66 reports).
1 FDA recall record name this device's identifier, 1 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
- 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-3174-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device66
- Leak/Splash50
- Material Puncture/Hole32
- Detachment of Device or Device Component23
- Material Deformation15
- Crack3
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions142
- Hemorrhage/Blood Loss/Bleeding16
Recent adverse event reports
The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3 WE REALIZED IN A 2-3 DAY PERIOD THAT THE WHOLE SYSTEM WOULD FILL WITH AIR ONLY WHEN THE BLOOD WENT INTO THE LINES. WHEN IT ACTUALLY HAPPENED TO TWO DIFFERENT PATIENTS ON THE SAME SHIFT IS WHEN THEY REALIZED THAT IT PROBABLY WAS THE LINES SO WE PULLED ALL THAT LOT NUMBER WHICH ENDED UP BEING ONLY A CASE (36) NO. PATIENTS INVOLVED: 5-6. DATE OF INCIDENT: ON (B)(6) 2023, ON (B)(6)2023, ON (B)(6)2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475314 ↗MalfunctionJan 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 6. WE REALIZED IN A 2-3 DAY PERIOD THAT THE WHOLE SYSTEM WOULD FILL WITH AIR ONLY WHEN THE BLOOD WENT INTO THE LINES. WHEN IT ACTUALLY HAPPENED TO TWO DIFFERENT PATIENTS ON THE SAME SHIFT IS WHEN THEY REALIZED THAT IT PROBABLY WAS THE LINES SO WE PULLED ALL THAT LOT NUMBER WHICH ENDED UP BEING ONLY A CASE (36) NO. PATIENTS INVOLVED: 5-6 DATE OF INCIDENT: (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475305 ↗MalfunctionJan 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1 WE REALIZED IN A 2-3 DAY PERIOD THAT THE WHOLE SYSTEM WOULD FILL WITH AIR ONLY WHEN THE BLOOD WENT INTO THE LINES. WHEN IT ACTUALLY HAPPENED TO TWO DIFFERENT PATIENTS ON THE SAME SHIFT IS WHEN THEY REALIZED THAT IT PROBABLY WAS THE LINES SO WE PULLED ALL THAT LOT NUMBER WHICH ENDED UP BEING ONLY A CASE (36) NO. PATIENTS INVOLVED: 5-6 DATE OF INCIDENT: 12/23/23, 12/24/23, 12/26/23.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475304 ↗MalfunctionJan 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2. WE REALIZED IN A 2-3 DAY PERIOD THAT THE WHOLE SYSTEM WOULD FILL WITH AIR ONLY WHEN THE BLOOD WENT INTO THE LINES. WHEN IT ACTUALLY HAPPENED TO TWO DIFFERENT PATIENTS ON THE SAME SHIFT IS WHEN THEY REALIZED THAT IT PROBABLY WAS THE LINES SO WE PULLED ALL THAT LOT NUMBER WHICH ENDED UP BEING ONLY A CASE (36) NO. PATIENTS INVOLVED: 5-6 DATE OF INCIDENT: 12/23/23, 12/24/23, 12/26/23.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475303 ↗MalfunctionJan 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 5. WE REALIZED IN A 2-3 DAY PERIOD THAT THE WHOLE SYSTEM WOULD FILL WITH AIR ONLY WHEN THE BLOOD WENT INTO THE LINES. WHEN IT ACTUALLY HAPPENED TO TWO DIFFERENT PATIENTS ON THE SAME SHIFT IS WHEN THEY REALIZED THAT IT PROBABLY WAS THE LINES SO WE PULLED ALL THAT LOT NUMBER WHICH ENDED UP BEING ONLY A CASE (36). NO. PATIENTS INVOLVED: 5-6. DATE OF INCIDENT: (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475292 ↗MalfunctionJan 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 4: WE REALIZED IN A 2-3 DAY PERIOD THAT THE WHOLE SYSTEM WOULD FILL WITH AIR ONLY WHEN THE BLOOD WENT INTO THE LINES. WHEN IT ACTUALLY HAPPENED TO TWO DIFFERENT PATIENTS ON THE SAME SHIFT IS WHEN THEY REALIZED THAT IT PROBABLY WAS THE LINES SO WE PULLED ALL THAT LOT NUMBER WHICH ENDED UP BEING ONLY A CASE (36) NO. PATIENTS INVOLVED: 5-6 DATE OF INCIDENT: (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475291 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D. LOT # 20255031. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301398 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 7: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20255031. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301397 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 6: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20255031. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301396 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 5: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20255031. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301395 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20255031. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301384 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 4: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20255031. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301377 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20255031. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301376 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20955010. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301276 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20955010. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301273 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 5: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20955010. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301270 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D, LOT # 20955010. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301269 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 7: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20955010. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301268 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 4: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20955010. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301267 ↗MalfunctionDec 11, 2023Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: EVENT 6: BRIEF INQUIRY DESCRIPTION: SLICES IN BLOOD PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: SLICES NOTED IN BLOOD PUMP SEGMENTS OF APPROXIMATELY 7 ADDITIONAL BLOODLINES FROM SL-2000M2095D LOT # 20955010. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301266 ↗MalfunctionSep 12, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: LARGE ARTERIAL CLAMP DOES NOT CLOSE COMPLETELY, CAUSING BLOOD TO LEAK DURING TAKE-OFF. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17728369 ↗MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: THE ARTERIAL POD IS BREAKING OFF FROM THE TUBING WHEN THEY ARE BEING PUT IN THE MACHINE (BREAKING RIGHT IN TWO) BEFORE THEY ARE EVEN IN THE ROLLER CLAMP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17161816 ↗MalfunctionJun 18, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: SCREW ON THE TUBING LEAKS FROM THE CONNECTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17149361 ↗MalfunctionJun 14, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation
AS REPORTED BY THE USER FACILITY: EVENT 3 : DESCRIPTION: VENOUS SIDE OF LINES ARE MOLDED SHUT AND WERE PARTLY OPEN WHEN PUT ON DIALYZER WILL LEAK BLOOD. THE VENOUS PORT IS THE PROBLEM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17124229 ↗MalfunctionJun 14, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation
AS REPORTED BY THE USER FACILITY: EVENT 1 : DESCRIPTION: VENOUS SIDE OF LINES ARE MOLDED SHUT AND WERE PARTLY OPEN WHEN PUT ON DIALYZER WILL LEAK BLOOD. THE VENOUS PORT IS THE PROBLEM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17124218 ↗
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-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