Hemodialysis Bloodlines B3-4630M4705Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046955348848), received between Mar 28, 2025 and Feb 20, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (4 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.

Recalls naming this device

1. 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-1803-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MICROBUBBLES IN ARTERIAL SIDE OF LINE. TO ENSURE THAT THERE WAS NOT A LEAK COMING FROM THE TUBING BEING SCREWED ON TO THE CVC LUMENS IMPROPERLY, FACILITY PAUSED THE HD TREATMENT AND DID A STERILE DISCONNECT TO ASPIRATE FROM BOTH LUMENS OF CVC. NO AIR WAS ASPIRATED, SO HD TUBING WAS THEN RECONNECTED AND TREATMENT WAS RESUMED. MICRO BUBBLING CONTINUED THROUGHOUT ENTIRE TREATMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400954 ↗
• InjuryFeb 9, 2026Air/Gas in Device

  ACCORDING TO THE COMPLAINANT, THERE WERE MICRO AIR BUBBLES PRESENT IN ARTERIAL SIDE OF LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290365 ↗
• InjuryFeb 9, 2026Air/Gas in Device

  ACCORDING TO THE COMPLAINANT, THERE WERE MICRO AIR BUBBLES PRESENT IN ARTERIAL SIDE OF LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290330 ↗
• InjuryFeb 5, 2026Air/Gas in Device

  ACCORDING TO THE COMPLAINANT, THERE WERE MICRO AIR BUBBLES PRESENT IN ARTERIAL SIDE OF LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271913 ↗
• MalfunctionMar 28, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE COMPLAINANT, DURING THE TREATMENT, THE HEMODIALYSIS BLOOD TUBING SET (MATERIAL # B3-4630M4705, LOT # 21151001) WAS FOUND TO HAVE A LEAK AT THE TIP OF THE VENOUS CHAMBER. THE PATIENT'S BLOOD WAS RETURNED BACK. THE COMPLAINT DEVICE WAS DISCARDED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722133 ↗