INTRAVIA 2B8012Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 00085412003191), received between Dec 28, 2017 and Sep 30, 2026 — classified as 119 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (65 reports).

3 other recalls cover devices cleared under the same FDA submission (K964853); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 119 reports, 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 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 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 ↗
• MalfunctionAug 20, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355488 ↗
• MalfunctionAug 20, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355486 ↗
• MalfunctionMay 1, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT LEAST TWO (2) 250 ML INTRAVIA CONTAINERS HAD CLEAR, STRAND-LIKE CONTAMINANTS FLOATING IN THE BAGS. THIS WAS OBSERVED WHEN PERFORMING BIANNUAL MEDIA FILLS. THE CONTAMINANTS WERE FURTHER DESCRIBED AS "SMALL WISPY STRANDS" AND THE STRANDS APPEARED TO BE PLASTIC. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059722 ↗
• MalfunctionApr 29, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 250ML INTRAVIA CONTAINER HAD PARTICULATE MATTER/FOREIGN MATERIAL LOCATED INSIDE THE SOLUTION/FLUID PATH. AFTER THE PRODUCT WAS FILLED WITH SOLUTION (AFTER ADDING ANOTHER MEDICATION OR AFTER RECONSTITUTION), THE PARTICULATE MATTER WAS OBSERVED NEAR THE PERIPHERY. THIS ISSUE WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037716 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) 250 ML INTRAVIA CONTAINERS HAVE SMALL PLASTIC PIECES INSIDE OF THE BAGS. THIS WAS OBSERVED DURING USE IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887757 ↗
• MalfunctionMar 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER HAD SMALL, HARD PLASTIC PIECES INSIDE OF THE BAG. THE ISSUE WAS NOTICED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694949 ↗
• MalfunctionMar 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER HAD SMALL, HARD PLASTIC PIECES INSIDE OF THE BAGS. THE ISSUE WAS NOTICED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694948 ↗
• MalfunctionMar 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER HAD SMALL, HARD PLASTIC PIECES INSIDE OF THE BAGS. THE ISSUE WAS NOTICED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694271 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PORT OF AN INTRAVIA CONTAINER 250 ML CAPACITY WAS SEPARATED. THIS OCCURRED AFTER REMOVING THE TAMPER PROOF SEAL FROM THE BAG PORT AND CLEANING THE PORT WITH ALCOHOL. THE PORT THEN SEPARATED FROM THE BAG, CAUSING SOME OF THE DRUG TO DRIP OUT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492893 ↗
• MalfunctionFeb 10, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A VERY SMALL PIECE OF PLASTIC WAS FLOATING IN A 250ML INTRAVIA CONTAINER. THE PARTICULATE MATTER WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309224 ↗
• MalfunctionSep 25, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT AN UNSPECIFIED SPIKE/TUBING WAS DIFFICULT TO REMOVE FROM AN UNSPECIFIED AMOUNT OF 250ML INTRAVIA CONTAINERS. THIS ISSUE OCCURRED WHILE CHANGING THE EPIDURAL BAGS. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED AT THE TIME OF 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 23151944 ↗
• MalfunctionSep 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) 250 ML INTRAVIA CONTAINERS HAD PLASTIC PARTICLES INSIDE THE BAG. THIS ISSUE WAS IDENTIFIED DURING COMPOUNDING WHILE ADDING SOLUTION/DRUG TO THE BAG AND/OR WHEN REMOVING AIR FROM BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098176 ↗
• MalfunctionSep 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) 250 ML INTRAVIA CONTAINERS HAD PLASTIC PARTICLES INSIDE THE BAG. THIS ISSUE WAS IDENTIFIED DURING COMPOUNDING WHILE ADDING SOLUTION/DRUG TO THE BAG AND/OR WHEN REMOVING AIR FROM BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098051 ↗
• MalfunctionJun 13, 2025Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE TIP PROTECTORS (BLUE PORT) OF SIXTY-THREE (63) 250 ML INTRAVIA CONTAINERS WERE FALLING OFF. THIS ISSUE WAS FURTHER DESCRIBED AS LOOSE TIP PROTECTORS FOUND DURING AN INSPECTION IN THE POST COMPOUNDING DEPARTMENT PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202559 ↗
• MalfunctionJun 9, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE PORT CAPS WERE FALLING OFF FROM FIFTY SEVEN (57) 250 ML CAPACITY INTRAVIA CONTAINERS. THE ISSUE WAS FURTHER DESCRIBED AS, "THE BLUE PORT WAS DETACHING FROM THE BAGS". THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170799 ↗
• MalfunctionApr 17, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER 250 ML CAPACITY LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS; THE BOTTOM RIGHT CURVE WAS OBSERVED TO BE TORN. THIS WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856352 ↗
• MalfunctionApr 2, 2025Contamination; Contamination

  IT WAS REPORTED THAT A 250ML INTRAVIA CONTAINER HAD A BLACK MARKING INSIDE THE BAG. THIS WAS OBSERVED AFTER COMPOUNDING WITH CYCLOPHOSPHAMIDE. THE TECHNICIAN ATTEMPTED TO REMOVE THE BLACK MARKING AND REALIZED THE MARKING WAS INSIDE THE BAG ON THE TOP (EMBEDDED). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756408 ↗
• MalfunctionFeb 25, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A 250 ML INTRAVIA CONTAINER HAD A SMALL PUNCTURE/PINHOLE ON THE BACK OF THE BAG WHICH RESULTED IN A LEAK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462179 ↗
• MalfunctionFeb 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UNSPECIFIED PARTICULATES WERE OBSERVED IN FOUR (04) INTRAVIA CONTAINERS 250 ML CAPACITY. THE DEVICES CONTAINED UNSPECIFIED SOLUTIONS. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365667 ↗
• MalfunctionFeb 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 250ML INTRAVIA CONTAINER LEAKED FROM THE NEEDLE STRIKE (SEPTUM) ON THE DOSING PORT. THIS WAS NOTICED BEFORE PATIENT USE. THE BAG CONTAINED FENTANYL 2MCG/ML-BUPIVACAINE 0.1%. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294686 ↗
• MalfunctionJan 6, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER 250 ML CAPACITY LEAKED FROM A TEAR ON THE SIDE OF THE DOSING PORT WHERE THE PORT TUBING FROM THE BAG MEETS THE PORT INSERT. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080136 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964853. One submission often covers many models, so check the product and lot details in each record.

• Z-0485-2018 · Jul 27, 2017 · Terminated
  Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
• Z-0084-2015 · Sep 16, 2014 · Terminated
  Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use i
• Z-0085-2015 · Sep 16, 2014 · Terminated
  Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is in