Volumat™ Line VL PR44-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04250273731965), received between Dec 8, 2025 and Mar 20, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K121613, K220301); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: MULTIPLE ISSUES REPORTED AT THE PORT SITE WITH THIS LINE- THE COMMON ISSUE THROUGH THESE COMPLAINTS APPEARS TO BE THE DISTAL PORT. UNABLE TO PUSH MEDICATION THROUGH THE PORT. OTHER ISSUES INCLUDE LEAKING AT PORT FILTER AND ISSUES WITH THE PROXIMAL PORT NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647003 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: MULTIPLE ISSUES REPORTED AT THE PORT SITE WITH THIS LINE- THE COMMON ISSUE THROUGH THESE COMPLAINTS APPEARS TO BE THE DISTAL PORT. UNABLE TO PUSH MEDICATION THROUGH THE PORT. OTHER ISSUES INCLUDE LEAKING AT PORT FILTER AND ISSUES WITH THE PROXIMAL PORT NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647002 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: PATIENT WAS RECEIVING RITUXIMAB IV, THE LINE WAS PRIMED WITH DRUG FROM PHARMACY, RECEIVED BY TREATING UNIT AND ADMINISTERED TO PATIENT. THE DRUG RAN DRY DURING INFUSION; THEREFORE, AIR WAS REQUIRED TO BE WITHDRAWN FROM THE LINE. NURSE WAS UNABLE TO DO SO THEREFORE BECAUSE IT WAS DISCOVERED THE PORT 12A (SECOND LOWEST PORT ON TUBING LINE) WAS BLOCKED/MALFUNCTIONING. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646572 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: PT WAS BEING TREATED WITH FOLFIRI, TREATMENT HAD BEEN INITIATED, APPROX 29 ML OF IRINOTECAN HAD INFUSED. LINES BEING USED WERE A PRIMARY SET (NON-PUMP LINE, REFERRED TO AS RESCUE LINE") DIRECTLY CONNECTED TO PATIENT'S PORT GRIPPER CONNECTOR) A VOLUMAT LINE (PRIMARY PUMP LINE NON-FILTERED) CONNECTED TO THE LOWEST PORT OF THE "RESCUE LINE" AND A SECOND VOLUMAT LINE CONNECTED TO LOWEST PORT OF 1ST VOLUMAT LINE. BOTH PUMP LINES WERE IN PUMPS AND IN USE. VOLUMAT LINE 1 WAS PUMPED AS PROGRAMMED BUT 2ND VOLUMAT PUMP WAS ALARMING "DISTAL OCCLUSION". UPON INVESTIGATION IT WAS FOUND THAT THE LOWEST PORT OF THE 1ST VOLUMAT LINE WAS OBSTRUCTED/NOT FUNCTIONING. THIS WAS CONFIRMED BY CONNECTING A 10 ML NS SYRINGE AND ATTEMPTING TO FLUSH THROUGH WHEN NO LONGER CONNECTED TO PATIENT. THERE WOULD HAVE BEEN APPROX. 20 ML OF IRINOTECAN IN THE LINE THAT WAS DISCARDED ALONG WITH THE VOLUMAT LINE THAT HAD MALFUNCTIONED." NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646571 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: SEVERAL [IV] LINES THAT WERE STARTED [IN OPERATING ROOM] HAVE DISTAL PORTS THAT ARE UNABLE TO BE ACCESSED. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646570 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: SEVERAL [IV] LINES THAT WERE STARTED [IN OR] HAVE DISTAL PORTS THAT ARE UNABLE TO BE ACCESSED. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646568 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: LOWEST PORT OF VOLUMAT LINE (12B) (PRIMARY PUMP LINE) BLOCKED/UNABLE TO FLUSH. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646567 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: PATIENT WAS RECEIVING RITUXIMAB IV, THE LINE WAS PRIMED WITH DRUG FROM PHARMACY, RECEIVED BY TREATING UNIT AND ADMINISTERED TO PATIENT. THE DRUG RAN DRY DURING INFUSION; THEREFORE AIR WAS REQUIRED TO BE WITHDRAWN FROM THE LINE. NURSE WAS UNABLE TO DO SO THEREFORE BECAUSE IT WAS DISCOVERED THE PORT 12A (SECOND LOWEST PORT ON TUBING LINE) WAS BLOCKED/MALFUNCTIONING. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646566 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: PT WAS BEING TREATED WITH FOLFIRI, TREATMENT HAD BEEN INITIATED, APPROX 29 ML OF IRINOTECAN HAD INFUSED. LINES BEING USED WERE A PRIMARY SET (NON PUMP LINE, REFERRED TO AS RESCUE LINE") DIRECTLY CONNECTED TO PATIENT'S PORT GRIPPER CONNECTOR) A VOLUMAT LINE (PRIMARY PUMP LINE NON-FILTERED) CONNECTED TO THE LOWEST PORT OF THE "RESCUE LINE" AND A SECOND VOLUMAT LINE CONNECTED TO LOWEST PORT OF 1ST VOLUMAT LINE. BOTH PUMP LINES WERE IN PUMPS AND IN USE. VOLUMAT LINE 1 WAS PUMPED AS PROGRAMMED BUT 2ND VOLUMAT PUMP WAS ALARMING "DISTAL OCCLUSION". UPON INVESTIGATION IT WAS FOUND THAT THE LOWEST PORT OF THE 1ST VOLUMAT LINE WAS OBSTRUCTED/NOT FUNCTIONING. THIS WAS CONFIRMED BY CONNECTING A 10 ML NS SYRINGE AND ATTEMPTING TO FLUSH THROUGH WHEN NO LONGER CONNECTED TO PATIENT. THERE WOULD HAVE BEEN APPROX. 20 ML OF IRINOTECAN IN THE LINE THAT WAS DISCARDED ALONG WITH THE VOLUMAT LINE THAT HAD MALFUNCTIONED." NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646565 ↗
• MalfunctionMar 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: LOWEST PORT OF VOLUMAT LINE (12B) (PRIMARY PUMP LINE) BLOCKED/UNABLE TO FLUSH. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646564 ↗
• MalfunctionDec 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: PRIMARY LINE INFUSING CHEMOTHERAPY LEAKED AT THE DISTAL PORT (PORT FARTHEST FROM THE PUMP). THE GLUE APPEARED TO LOOK STRINGY AND LET GO FROM THE PLASTIC END OF THE PORT. A SMALL AMOUNT OF CHEMOTHERAPY LEAKED ONTO THE PATIENT'S ARM, CHAIR, AND FLOOR. NO ADVERSE EVENT WAS COMMUNICATED. INVESTIGATION SUMMARY AS FOLLOWS: 1. REPORTED COMPLAINT LEAKAGE AT NEEDLE FREE PORT 2. QUANTITY OF THE SAMPLE(S) NO COMPLAINT SAMPLE AVAILABLE FOR INVESTIGATION, ONLY ONE PHOTO 3. CONCERNED PRODUCT CODE/BATCH INFUSION SET VL PR44-12 (NAM) - M46445780 / BATCH UNKNOWN 4. INVESTIGATION REPORT WE HAVE NOT RECEIVED A COMPLAINT SAMPLE FOR INVESTIGATION. WE RECEIVED ONE PHOTO WITCH SHOWS PART OF OUR PRODUCT INSIDE THE FOIL BAG - ONLY K-ZERO AND TUBE. IT WAS VISIBLE A DROPS OF FLUID INSIDE THE BAG. NEVERTHELESS, IT IS NOT CLEARLY VISIBLE A PLACE OF LEAKAGE. BASED ON PHOTO WE DID NOT ABLE TO CONFIRM WHERE THE LEAKAGE OCCURED. AS WE DID NOT RECEIVE THE BATCH NUMBER, AN INSPECTION OF RETAINED SAMPLES AND REVIEW OF BATCH DOCUMENTATION WAS NOT POSSIBLE. WITHOUT FAULTY SAMPLE AND BATCH NUMBER, A MORE DETAILED INVESTIGATION WAS NOT POSSIBLE. IN THE LAST 12 MONTHS (FROM (B)(6) 2024 TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751493 ↗
• MalfunctionDec 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: PRIMARY LINE INFUSING CHEMOTHERAPY LEAKED AT THE DISTAL PORT (PORT FARTHEST FROM THE PUMP). THE GLUE APPEARED TO LOOK STRINGY AND LET GO FROM THE PLASTIC END OF THE PORT. A SMALL AMOUNT OF CHEMOTHERAPY LEAKED ONTO THE PATIENT'S ARM, CHAIR, AND FLOOR. NO ADVERSE EVENT WAS COMMUNICATED. INVESTIGATION SUMMARY AS FOLLOWS: 1. REPORTED COMPLAINT LEAKAGE AT NEEDLE FREE PORT 2. QUANTITY OF THE SAMPLE(S) NO COMPLAINT SAMPLE AVAILABLE FOR INVESTIGATION, ONLY ONE PHOTO 3. CONCERNED PRODUCT CODE/BATCH INFUSION SET VL PR44-12 (NAM) - M46445780 / BATCH UNKNOWN 4. INVESTIGATION REPORT WE HAVE NOT RECEIVED A COMPLAINT SAMPLE FOR INVESTIGATION. WE RECEIVED ONE PHOTO WITCH SHOWS PART OF OUR PRODUCT INSIDE THE FOIL BAG - ONLY K-ZERO AND TUBE. IT WAS VISIBLE A DROPS OF FLUID INSIDE THE BAG. NEVERTHELESS, IT IS NOT CLEARLY VISIBLE A PLACE OF LEAKAGE. BASED ON PHOTO WE DID NOT ABLE TO CONFIRM WHERE THE LEAKAGE OCCURED. AS WE DID NOT RECEIVE THE BATCH NUMBER, AN INSPECTION OF RETAINED SAMPLES AND REVIEW OF BATCH DOCUMENTATION WAS NOT POSSIBLE. WITHOUT FAULTY SAMPLE AND BATCH NUMBER, A MORE DETAILED INVESTIGATION WAS NOT POSSIBLE. IN THE LAST 12 MONTHS (FROM (B)(6) 2024 TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751487 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121613, K220301. One submission often covers many models, so check the product and lot details in each record.

• Z-2064-2019 · Jun 24, 2019 · Terminated
  VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to
• Z-0362-2019 · Dec 2, 2017 · Terminated
  Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to