INTRAVIA 2B8011Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00085412003467), received between Jan 19, 2018 and Sep 24, 2026 — classified as 127 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (58 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261336 ↗
• MalfunctionAug 4, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133739 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068890 ↗
• MalfunctionJun 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE(3) INTRAVIA CONTAINERS LEAKED ACTIVELY FROM "BLADDER SEAM". THE ISSUE WAS NOTICED PRIOR TO PATIENT USE. THE DEVICES CONTAINED FENTANYL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25527623 ↗
• MalfunctionMay 1, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT LEAST ONE INTRAVIA CONTAINER HAD SMALL WISPY STRANDS (APPROXIMATELY 0.25 INCHES) IN LENGTH WERE OBSERVED FLOATING IN THE CONTAINER AFTER FLUID HAD BEEN ADDED. IT WAS FURTHER MENTIONED THAT "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 25060174 ↗
• MalfunctionMar 18, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) INTRAVIA CONTAINERS 150 ML CAPACITY HAD PARTICULATE MATTER INSIDE THE STERILE BAG, DESCRIBED AS SMALL, HAIRLIKE, TINY PARTICULATES. THIS 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 24626355 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER LEAKED FROM 'THE SEAL BETWEEN THE IV BAG AND THE INJECTION PORT' UPON REMOVAL OF THE BLUE TAMPER SEAL, DURING POST-COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299893 ↗
• MalfunctionFeb 6, 2026Degraded; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT OF AN INTRAVIA CONTAINER 150 ML CAPACITY WAS DRY AND LEAKED. THIS WAS OBSERVED DURING SETUP IN THE PHARMACY DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280632 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER LEAKED AT THE PORT. THE ISSUE OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263071 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 150 ML CAPACITY INTRAVIA CONTAINER LEAKED FROM THE CONNECTION POINT BETWEEN THE TUBING AND THE INJECTION PORT. THIS 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 23975336 ↗
• MalfunctionDec 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER HAD SMALL PLASTIC PARTICLE WAS OBSERVED IN THE SOLUTION. THE ISSUE OCCURRED AFTER COMPOUNDING 5FU (5-FLUOROURACIL) BAG FOR INFUSION. A NON-BAXTER ADAPTER WAS USED TO SPIKE INTO PORT OF THE EMPTY BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858105 ↗
• MalfunctionDec 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A 150ML INTRAVIA CONTAINER HAD A HOLE IN THE FILLING PORT. THIS ISSUE WAS OBSERVED DURING THE COMPOUNDING PROCESS PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839872 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 150ML INTRAVIA CONTAINER WAS LEAKING FROM THE SEAM NEXT TO THE PORT. THE LEAK WAS OBSERVED DURING SHIPPING FOR DISTRIBUTION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823985 ↗
• MalfunctionOct 27, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 150ML INTRAVIA CONTAINERS HAD CONNECTION ISSUES. THIS ISSUE WAS DESCRIBED AS, ¿DIFFICULTIES WITH ATTACHING AND REMOVING THE TUBING FROM THE EPIDURAL BAG¿ AND ¿THIS WAS LEADING TO DAMAGED BAGS AND TUBING CAUSING DISRUPTIONS IN THE EPIDURAL INFUSIONS¿. THESE ISSUES WERE IDENTIFIED DURING USE. 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 23395969 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER 150 ML CAPACITY LEAKED AT "THE SEAL ON THE BOTTOM SEAM OF THE BAG, TO THE LEFT OF THE DOSING PORT". IT WAS SUSPECTED THAT THE ISSUE OCCURRED DURING SHIPMENT. THIS WAS DISCOVERED UPON RECEIPT AT THE HOSPITAL PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947748 ↗
• MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 150 ML CAPACITY INTRAVIA CONTAINER LEAKED WHEN THE NURSE WAS TRYING TO PULL THE TUBING SPIKE OUT OF THE BAG. THIS WAS OBSERVED DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331860 ↗
• MalfunctionJun 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THREE (3) 150ML INTRAVIA CONTAINERS HAD PARTICULATE MATTER (PM) IN THE BAGS. IT WAS OBSERVED THAT WHEN THE BAGS WERE SPIKED AT A SLIGHT ANGLE A PIECE OF PLASTIC OCCASIONALLY BROKE OFF INTO THE BAG. THE PM APPEARED TO BE A PIECE OF THE PORT AND WAS DESCRIBED AS, ¿SMALL, THIN, CLEAR PIECE OF PLASTIC FLOATING IN THE SOLUTION IN THE BAG¿. THE BAGS WERE BEING FILLED WITH PIPERACILLIN-TAZOBACTAM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235629 ↗
• MalfunctionJun 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT (2-3 BAGS) OF 150 ML CAPACITY INTRAVIA CONTAINERS HAD PARTICULATE MATTER INSIDE THE BAG. WHEN SPIKING THE BAGS, A PIECE OF PLASTIC WILL OCCASIONALLY BREAK OFF FROM THE BAG AND ENTER THE BAG. 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 22215120 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Failure to Disconnect; Fluid/Blood Leak; Failure to Disconnect

  IT WAS REPORTED UNSPECIFIED UNITS OF 150 ML CAPACITY INTRAVIA CONTAINERS LEAKED WHEN THE NURSES HAD DIFFICULTIES IN UNSPIKING. THE ISSUE WAS FURTHER DESCRIBED AS; NURSE HAD TO CUT OPEN THE BAG TO WASTE THE REST OF THE DRUG INSTEAD OF TRYING TO DEAL WITH THE PORT. 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 21968881 ↗
• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) 150ML INTRAVIA CONTAINERS LEAKED AT THE SEAM LOCATED IN BETWEEN TWO PORTS. THIS WAS NOTICED DURING SHIPPING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777888 ↗
• MalfunctionMar 26, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) 150ML INTRAVIA CONTAINERS LEAKED. THE LEAKS WERE EITHER FROM THE SEAM NEXT TO THE PORT , FROM THE CONNECTION BETWEEN TWO COMPONENTS, OR FROM THE INJECTION PORT; AT LEAST ONE (1) BAG HAD AN OBSERVED FRANGIBLE DEFECT. THIS WAS OBSERVED DURING THE INSPECTION AND LABELING PROCESS. THE BAGS WERE FILLED USING NON-BAXTER NEEDLES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702079 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVIA CONTAINER 150 ML CAPACITY LEAKED AROUND THE BLUE PORT. THIS OCCURRED AFTER COMPOUNDING WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697179 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing

  IT WAS REPORTED THAT A 150ML INTRAVIA CONTAINER SPILLED FLUID OUT FROM THE BAG. THIS OCCURRED AS SOON AS THE BLUE TAG WAS REMOVED TO CONNECT THE BAG TO THE TUBING, BEFORE ATTEMPTING TO PUNCTURE THE SEAL. UPON FURTHER INSPECTION, THE TUBING PORT (COVERED BY A TRANSLUCENT BLUE TAG UNTIL REMOVED PRIOR TO USE) SEEMED TO BE MISSING THE "NARROWED EXTENSION THAT CONTAINS THE SEAL". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335003 ↗
• MalfunctionJan 31, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATES WERE OBSERVED IN TWO (02) 150 ML INTRAVIA CONTAINERS. THIS WAS OBSERVED DURING THE COMPOUNDING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284075 ↗

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-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
• 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