Volumat LineRecalls & reported problems across all models
Fresenius Kabi AG · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 8 models of Volumat Line by Fresenius Kabi AG in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2016 and May 18, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (22 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
Reports received per month, all models
Most reported Volumat Line problems
Device problems
- No Apparent Adverse Event42
- Connection Problem22
- Obstruction of Flow12
- Fluid/Blood Leak9
- Break6
- Infusion or Flow Problem6
- Leak/Splash4
- Chemical Spillage1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Information3
- No Known Impact Or Consequence To Patient3
- Chemical Exposure2
Volumat Line models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Volumat™ Line VL SP40-11Pump, Infusion14 reports
- Volumat™ Line VL PR44-12Pump, Infusion12 reports
- Volumat™ Line VL SL00-XPPump, Infusion10 reports
- Volumat™ Line VL PN 02-1Pump, Infusion4 reports
- Volumat™ Line VL ST 02-0Pump, Infusion3 reports
- Volumat™ Line VL ST 10-0Pump, Infusion3 reports
- Volumat™ Line VL PR 72-11Pump, Infusion2 reports
- Volumat™ Line VL ON 72-1Pump, Infusion1 report
Recent Volumat Line adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Break; Connection Problem; No Apparent Adverse Event
CUSTOMER REPORTED A SAFETY CONCERN REGARDING THE SECONDARY INFUSION SET. THIS WAS A NEAR MISS AND NOTICED PRIOR TO HANGING ON THE PATIENT, BUT THE TIP OF THE SECONDARY INFUSION SET SPIKE BROKE OFF AND WAS FLOATING IN THE ANTIBIOTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210601 ↗MalfunctionMay 18, 2026Break; Connection Problem; No Apparent Adverse Event
CUSTOMER REPORTED A SAFETY CONCERN REGARDING THE SECONDARY INFUSION SET. THIS WAS A NEAR MISS AND NOTICED PRIOR TO HANGING ON THE PATIENT, BUT THE TIP OF THE SECONDARY INFUSION SET SPIKE BROKE OFF AND WAS FLOATING IN THE ANTIBIOTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210600 ↗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 ↗MalfunctionApr 10, 2026Break; Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: CUSTOMER REPORTED WE HAD AN INCIDENT TODAY WHERE THE SPIKE BROKE OFF COMPLETELY. ALSO GETTING REPORTS THAT THE SPIKE IS SLIDING OUT OF THE BAGS. INVESTIGATION RESULTS: 1. REPORTED COMPLAINT: BROKEN SPIKE. 2. QUANTITY AND CONDITION OF SAMPLE(S): FRESENIUS KABI HAS RECEIVED PICTURES. 3. CONCERNED PRODUCT CODE / BATCH: VL SL00-XP (PVC-FREE), M77460052, BATCH UNKNOWN. 4. INVESTIGATION REPORT: FIRST PROVIDED PICTURE PRESENTS A PART OF OUR FRESENIUS PRODUCT VL SL00-XP (PVC-FREE). THE PRODUCT IS CLOSED IN PLASTIC BAG. THERE ARE VISIBLE TRANSPARENT DROPS OF LIQUID. WE SEE THE SPIKE IS BROKEN. ON THE SECOND PHOTO WE SEE THE SAME PRODUCT, HOWEVER THE WHOLE ARTICLE IS VISIBLE IN ORIGINALLY CLOSED PRIMARY PACKAGING. THE SPIKE IS NOT BROKEN ON THE PICTURE, WHICH SUGGEST THAT THERE WERE NO DAMAGE BEFORE USAGE. AS FRESENIUS KABI DID NOT RECEIVE BATCH NUMBER, IT IS NOT POSSIBLE TO PERFORM TESTS ON RETAIN SAMPLE. BATCH DOCUMENTATION OVERVIEW: AS THE BATCH NUMBER IS UNKNOWN, THE OVERVIEW IS NOT POSSIBLE. IN THE LAST 12 MONTHS (27-03-2025 TO 26-03-2026) FRESENIUS KABI HAVE RECEIVED ONLY THIS ONE COMPLAINT FOR THIS ARTICLE M77460052 WITH THE SAME REASON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24842130 ↗MalfunctionApr 10, 2026Break; Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: CUSTOMER REPORTED WE HAD AN INCIDENT TODAY WHERE THE SPIKE BROKE OFF COMPLETELY. ALSO GETTING REPORTS THAT THE SPIKE IS SLIDING OUT OF THE BAGS. INVESTIGATION RESULTS: 1. REPORTED COMPLAINT BROKEN SPIKE. 2. QUANTITY AND CONDITION OF SAMPLE(S) FRESENIUS KABI HAS RECEIVED PICTURES. 3. CONCERNED PRODUCT CODE / BATCH VL SL00-XP (PVC-FREE), M77460052, BATCH UNKNOWN 4. INVESTIGATION REPORT. FIRST PROVIDED PICTURE PRESENTS A PART OF OUR FRESENIUS PRODUCT VL SL00-XP (PVC-FREE). THE PRODUCT IS CLOSED IN PLASTIC BAG. THERE ARE VISIBLE A TRANSPARENT DROPS OF LIQUID. WE SEE THE SPIKE IS BROKEN. ON THE SECOND PHOTO WE SEE THE SAME PRODUCT, HOWEVER THE WHOLE ARTICLE IS VISIBLE IN ORYGINALLY CLOSED PRIMARY PACKAGING. THE SPIKE IS NOT BROKEN ON THE PICTURE, WHICH SUGGEST THAT THERE WERE NO DAMAGE BEFORE USAGE. AS FRESENIUS KABI DID NOT RECEIVE BATCH NUMBER, IT IS NOT POSSIBLE TO PERFORM TESTS ON RETAIN SAMPLE. BATCH DOCUMENTATION OVERVIEW: AS THE BATCH NUMBER IS UNKNOWN, THE OVERVIEW IS NOT POSSIBLE. IN THE LAST 12 MONTHS (27.03.2025 TO 26.03.2026 ) FRESENIUS KABI HAVE RECEIVED ONLY THIS ONE COMPLAINT FOR THIS ARTICLE M77460052 WITH THE SAME REASON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24842103 ↗MalfunctionApr 10, 2026Break; Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: CUSTOMER REPORTED WE HAD AN INCIDENT TODAY WHERE THE SPIKE BROKE OFF COMPLETELY. ALSO GETTING REPORTS THAT THE SPIKE IS SLIDING OUT OF THE BAGS. INVESTIGATION RESULTS: 1. REPORTED COMPLAINT BROKEN SPIKE 2. QUANTITY AND CONDITION OF SAMPLE(S) FRESENIUS KABI HAS RECEIVED PICTURES 3. CONCERNED PRODUCT CODE / BATCH VL SL00-XP (PVC-FREE), M77460052, BATCH UNKNOWN 4. INVESTIGATION REPORT FIRST PROVIDED PICTURE PRESENTS A PART OF OUR FRESENIUS PRODUCT VL SL00-XP (PVC-FREE). THE PRODUCT IS CLOSED IN PLASTIC BAG. THERE ARE VISIBLE A TRANSPARENT DROPS OF LIQUID. WE SEE THE SPIKE IS BROKEN. ON THE SECOND PHOTO WE SEE THE SAME PRODUCT, HOWEVER THE WHOLE ARTICLE IS VISIBLE IN ORIGINALLY CLOSED PRIMARY PACKAGING. THE SPIKE IS NOT BROKEN ON THE PICTURE, WHICH SUGGEST THAT THERE WERE NO DAMAGE BEFORE USAGE. AS FRESENIUS KABI DID NOT RECEIVE BATCH NUMBER, IT IS NOT POSSIBLE TO PERFORM TESTS ON RETAIN SAMPLE. BATCH DOCUMENTATION OVERVIEW: AS THE BATCH NUMBER IS UNKNOWN, THE OVERVIEW IS NOT POSSIBLE. IN THE LAST 12 MONTHS (27.03.2025 TO 26.03.2026 ) FRESENIUS KABI HAVE RECEIVED ONLY THIS ONE COMPLAINT FOR THIS ARTICLE M77460052 WITH THE SAME REASON AS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24842089 ↗MalfunctionApr 10, 2026Break; Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: CUSTOMER REPORTED WE HAD AN INCIDENT TODAY WHERE THE SPIKE BROKE OFF COMPLETELY. ALSO GETTING REPORTS THAT THE SPIKE IS SLIDING OUT OF THE BAGS. INVESTIGATION RESULTS: 1. REPORTED COMPLAINT: BROKEN SPIKE. 2. QUANTITY AND CONDITION OF SAMPLE(S): FRESENIUS KABI HAS RECEIVED PICTURES. 3. CONCERNED PRODUCT CODE / BATCH: VL SL00-XP (PVC-FREE), M77460052, BATCH: UNKNOWN. 4. INVESTIGATION REPORT: FIRST PROVIDED PICTURE PRESENTS A PART OF OUR FRESENIUS PRODUCT VL SL00-XP (PVC-FREE). THE PRODUCT IS CLOSED IN PLASTIC BAG. THERE ARE VISIBLE A TRANSPARENT DROPS OF LIQUID. WE SEE THE SPIKE IS BROKEN. ON THE SECOND PHOTO WE SEE THE SAME PRODUCT, HOWEVER THE WHOLE ARTICLE IS VISIBLE IN ORIGINALLY CLOSED PRIMARY PACKAGING. THE SPIKE IS NOT BROKEN ON THE PICTURE, WHICH SUGGEST THAT THERE WERE NO DAMAGE BEFORE USAGE. AS FRESENIUS KABI DID NOT RECEIVE BATCH NUMBER, IT IS NOT POSSIBLE TO PERFORM TESTS ON RETAIN SAMPLE. BATCH DOCUMENTATION OVERVIEW: AS THE BATCH NUMBER IS UNKNOWN, THE OVERVIEW IS NOT POSSIBLE. IN THE LAST 12 MONTHS (27.03.2025 TO 26.03.2026) FRESENIUS KABI HAVE RECEIVED ONLY THIS ONE COMPLAINT FOR THIS ARTICLE M77460052 WITH THE SAME REA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24841835 ↗MalfunctionMar 20, 2026Obstruction of Flow; Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: WILL NOT FLOW AND NURSE WAS TRYING TO ATTACH A FLUSH TO SEE IF SHE COULD FIGURE WHERE IT WAS CLAMPED AND WHERE SYRINGE IS ATTACHED IS THE PART THAT WILL "POP OFF" AND START DRIPPING. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651367 ↗MalfunctionMar 20, 2026Obstruction of Flow; Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: WILL NOT FLOW AND NURSE WAS TRYING TO ATTACH A FLUSH TO SEE IF SHE COULD FIGURE WHERE IT WAS CLAMPED AND WHERE SYRINGE IS ATTACHED IS THE PART THAT WILL "POP OFF" AND START DRIPPING. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651358 ↗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, 2026Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: CUSTOMER REPORTED THAT THEIR PRIMARY TUBING (M6445475) WHERE ANOTHER TUBING LINE CAN BE ATTACHED IS POPPING OUT CAUSING DRIPPING ONTO THE FLOOR OR PATIENT. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646759 ↗MalfunctionMar 20, 2026Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: CUSTOMER REPORTED THAT THEIR PRIMARY TUBING (M6445475) WHERE ANOTHER TUBING LINE CAN BE ATTACHED IS POPPING OUT CAUSING DRIPPING ONTO THE FLOOR OR PATIENT. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646758 ↗MalfunctionMar 20, 2026Connection Problem; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY THE CUSTOMER: CUSTOMER REPORTED THAT THEIR PRIMARY TUBING (M6445475) WHERE ANOTHER TUBING LINE CAN BE ATTACHED IS POPPING OUT CAUSING DRIPPING ONTO THE FLOOR OR PATIENT. NO ADVERSE EVENTS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646757 ↗
Other Fresenius Kabi AG products
All Fresenius Kabi AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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