INTRAVIARecalls & reported problems across all models

We found 7 models of INTRAVIA by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 455 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2017 and Sep 30, 2026 — classified as 3 injuries, 452 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (211 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INTRAVIA problems

INTRAVIA models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INTRAVIA 2B8011

  CONTAINER, I.V.
  127 reports
• INTRAVIA 2B8012

  CONTAINER, I.V.
  119 reports
• INTRAVIA 2B8013

  CONTAINER, I.V.
  64 reports
• INTRAVIA 2B8019

  CONTAINER, I.V.
  45 reports
• INTRAVIA 2B8014

  CONTAINER, I.V.
  43 reports
• INTRAVIA 2J8002

  CONTAINER, I.V.
  30 reports
• INTRAVIA 2J8003

  CONTAINER, I.V.
  27 reports

Recent INTRAVIA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  It was reported that an Empty INTRAVIA Container was actively leaking from the port and seam during inspection, labeling, and packaging activities. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941981 ↗
• MalfunctionSep 24, 2026Material Split, Cut or Torn

  It was reported that an INTRAVIA Container was difficult to remove from the administration set spike during a bag change, resulting in tearing of the container or breakage of the tail. This occurred during an unspecified process step, and it was unknown if a patient was connected during this event. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882706 ↗
• MalfunctionSep 18, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829550 ↗
• MalfunctionSep 17, 2026Device Contamination with Chemical or Other Material

  It was reported that four (4) Empty INTRAVIA Containers had pieces of the port membrane floating in the fluorouracil solution. This occurred during preparation of fluorouracil home infusions. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805438 ↗
• MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material

  It was reported that eight (8) Empty INTRAVIA Containers had white, plastic-like particulate matter. The issue was noticed during inspection for del Nido. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766739 ↗
• MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material

  It was reported that an INTRAVIA Container contained particulate matter inside the solution/fluid path. The particulate matter was described as 'very fine, almost hair-like' material floating within the solution. The issue was observed during setup after Sterile Water for Injection, dextrose 50% vial, sodium chloride 4 mEq/mL intravenous solution, and heparin (PF) 100 unit/mL were added for a neonatal custom intravenous infusion. The bag was quarantined and a new bag was compounded to resolve the issue. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766681 ↗
• MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material

  It was reported that an INTRAVIA Container contained particulate matter inside the solution/fluid path. The particulate matter was described as 'very fine, almost hair-like' material floating within the solution. The issue was observed during setup after Sterile Water for Injection, dextrose 50% vial, sodium chloride 4 mEq/mL intravenous solution, and heparin (PF) 100 unit/mL were added for a neonatal custom intravenous infusion. The bag was quarantined and a new bag was compounded to resolve the issue. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766671 ↗
• InjurySep 11, 2026Loose or Intermittent Connection; Device Contamination with Chemical or Other Material

  Describe Event, Problem, or Product Use Error: Multiple INTRAVENOUS bags, once spiked, had large membranes come loose from the port and floating in the INTRAVENOUS medication. 3 occurred in the same day and I had been informed that other bags had the same flaw from previous days.ANNEX A: 1371,2944 ANNEX E: 4582 ANNEX F: 4652 ANNEX G: 4755.REFERENCE REPORTS:MW6002230, MW6002231.THIS REPORT CAPTURES IV BAG 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740251 ↗
• InjurySep 11, 2026Loose or Intermittent Connection; Device Contamination with Chemical or Other Material

  Describe Event, Problem, or Product Use Error: Multiple INTRAVENOUS bags, once spiked, had large membranes come loose from the port and floating in the INTRAVENOUS medication. 3 occurred in the same day and I had been informed that other bags had the same flaw from previous days.ANNEX A: 1371,2944 ANNEX E: 4582 ANNEX F: 4652 ANNEX G: 4755.REFERENCE REPORTS:MW6002230, MW6002232.THIS REPORT CAPTURES IV BAG 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740190 ↗
• InjurySep 11, 2026Loose or Intermittent Connection; Device Contamination with Chemical or Other Material

  Describe Event, Problem, or Product Use Error: Multiple INTRAVENOUS bags, once spiked, had large membranes come loose from the port and floating in the INTRAVENOUS medication. 3 occurred in the same day and I had been informed that other bags had the same flaw from previous days.ANNEX A: 1371,2944 ANNEX E: 4582 ANNEX F: 4652 ANNEX G: 4755.REFERENCE REPORTS:MW6002231, MW6002232.THIS REPORT CAPTURES IV BAG 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739998 ↗
• MalfunctionSep 10, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721663 ↗
• MalfunctionSep 10, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721617 ↗
• MalfunctionSep 1, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50536356 ↗
• MalfunctionAug 28, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499593 ↗
• MalfunctionAug 20, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355488 ↗

Other Baxter International Inc. products

• CLEARLINK/CONTINU-FLO12 models · 824 reports · 6 recalls
• ONE-LINK12 models · 638 reports · 1 recall
• CLEARLINK19 models · 359 reports · 4 recalls
• CLEARLINK/DUO-VENT3 models · 150 reports
• INTERLINK17 models · 129 reports
• LOW RECIRCULATION VOLUME APD SET2 models · 69 reports
• Arthromatic/Uromatic3 models · 59 reports
• PrismaSATE2 models · 1 reports · 1 recall