Volumat™ Line VL PN 02-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04250273714371), received between Mar 14, 2026 and Apr 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Leak/Splash; Connection Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: LEAK AT Y-JOINT MICRON FILTER LINE RUNNING TPN AND LIPIDS BROKE\DISCONNECTED ENTIRELY, AFTER Y-SITE PORT ON IV LINE, CLOSEST TO PATIENT. TPN AND LIPIDS RAN ONTO PATIENT AND BEDDING, LEAVING PATIENT SOAKED. TPN BAG ALONG WITH LINES DISCARDED DUE TO RISK OF INFECTION. 1. REPORTED COMPLAINT LEAKAGE AT NEEDLE FREE PORT 2. QUANTITY OF SAMPLE(S) FRESENIUS KABI DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION 3. CONCERNED PRODUCT CODE / BATCH INFUSION SET VL PN 02-1 (USA), (M46442460), 32232375 4. INVESTIGATION REPORT DUE TO THE FACT THAT THERE WAS NO SAMPLES OR PICTURES PROVIDED, FRESENIUS KABI IS NOT ABLE TO CONFIRM IF THE FAILURE IS RELATED TO THE PRODUCTION PROCESS OR MATERIAL FAULT. BASED ON THE REASON FOR THE COMPLAINT, FRESENIUS KABI PERFORMED A VISUAL INSPECTION OF ALL RETAIN SAMPLES AND DO NOT SEE ANY DEFECTS. THE SETS ARE COMPLETE AND FREE FROM CONTAMINATION. IN THE NEXT STEP, FRESENIUS KABI PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND THE RESULTS WERE CORRECT. BATCH DOCUMENTATION REVIEW WAS PERFORMED AND FOLLOWING DATA WAS CHECKED: PRODUCTION ORDERS, IN PROCESS CONTROL AND FINAL INSPECTION RESULTS, COMPLIANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958263 ↗
• MalfunctionApr 22, 2026Leak/Splash; Connection Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: LEAK AT Y-JOINT MICRON FILTER LINE RUNNING TPN AND LIPIDS BROKE\DISCONNECTED ENTIRELY, AFTER Y-SITE PORT ON IV LINE, CLOSEST TO PATIENT. TPN AND LIPIDS RAN ONTO PATIENT AND BEDDING, LEAVING PATIENT SOAKED. TPN BAG ALONG WITH LINES DISCARDED DUE TO RISK OF INFECTION. 1. REPORTED COMPLAINT LEAKAGE AT NEEDLE FREE PORT 2. QUANTITY OF SAMPLE(S) FRESENIUS KABI DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION 3. CONCERNED PRODUCT CODE / BATCH INFUSION SET VL PN 02-1 (USA), (M46442460), 32232375 4. INVESTIGATION REPORT DUE TO THE FACT THAT THERE WAS NO SAMPLES OR PICTURES PROVIDED, FRESENIUS KABI IS NOT ABLE TO CONFIRM IF THE FAILURE IS RELATED TO THE PRODUCTION PROCESS OR MATERIAL FAULT. BASED ON THE REASON FOR THE COMPLAINT, FRESENIUS KABI PERFORMED A VISUAL INSPECTION OF ALL RETAIN SAMPLES AND DO NOT SEE ANY DEFECTS. THE SETS ARE COMPLETE AND FREE FROM CONTAMINATION. IN THE NEXT STEP, FRESENIUS KABI PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND THE RESULTS WERE CORRECT. BATCH DOCUMENTATION REVIEW WAS PERFORMED AND FOLLOWING DATA WAS CHECKED: PRODUCTION ORDERS, IN PROCESS CONTROL AND FINAL INSPECTION RESULTS, COMPLIANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958262 ↗
• MalfunctionMar 14, 2026Fluid/Blood Leak; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: WRITER PRIMED LINE AND HUNG BAG OF TPN WITH NO ISSUES. WRITER WAS THEN ALERTED AROUND 1900 THAT TPN WAS LEAKING FROM THE PUMP." WRITER WENT TO INSPECT AND FOUND THAT TUBING WAS INDEED LEAKING FROM PUMP (AT THE GREEN END OF THE RUBBER TIP THAT GOES INTO THE PUMP). WRITER REMOVED TPN AND HUNG D10 AS PER POLICY. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601469 ↗
• MalfunctionMar 14, 2026Fluid/Blood Leak; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: WRITER PRIMED LINE AND HUNG BAG OF TPN WITH NO ISSUES. WRITER WAS THEN ALERTED AROUND 1900 THAT TPN WAS LEAKING FROM THE PUMP." WRITER WENT TO INSPECT AND FOUND THAT TUBING WAS INDEED LEAKING FROM PUMP (AT THE GREEN END OF THE RUBBER TIP THAT GOES INTO THE PUMP). WRITER REMOVED TPN AND HUNG D10 AS PER POLICY. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601468 ↗

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