Hemodialysis Bloodlines B3-3632M3705Recalls & reported problems
B. Braun Medical Inc. · LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT · 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.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955348824), received between Feb 20, 2026 and Jun 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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
- 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-1802-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: INFORMING YOUR DEPARTMENT THAT OUR NURSES CAUGHT A LEAK WHILE THE FOLLOWING BLOODLINE WAS USED DURING A HEMODIALYSIS TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428830 ↗MalfunctionFeb 20, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MICRO AIR BUBBLES WERE PRESENT IN ARTERIAL SIDE OF LINE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400666 ↗
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.
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