Volumat™ Line VL SL00-XPRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04250273733884), received between Jan 12, 2026 and May 18, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K121613); 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 10 most recent of 10 reports, 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 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 ↗
• MalfunctionJan 12, 2026Infusion or Flow Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: WHEN WE HOOK A SECONDARY LINE LOT 32261475 TO THE PRIMARY LOT 32213335 ITS NOT PULLING AT ALL, IT'S THE LIKE THE PORT FOR THE PRIMARY ISN'T BEING PUSHED ALL THE WAY IN TO LET THE SECONDARY DRIP. NO ADVERSE EVENT REPORTED 1. REPORTED COMPLAINT MALFUNCTION AREA UNKNOWN 2. QUANTITY OF SAMPLE(S) WE DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION 3. CONCERNED PRODUCT CODE / BATCH INFUSION SET VL SP40-11, (M46445475), 32213335 4. INVESTIGATION REPORT DUE TO THE FACT THAT THERE WAS NO SAMPLES OR PICTURES PROVIDED WE ARE NOT ABLE TO CONFIRM IF THE FAILURE IS RELATED TO THE PRODUCTION PROCESS OR MATERIAL FAULT. BASED ON THE REASON FOR THE COMPLAINT, WE 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, WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND FOUND NO ABNORMALITIES. ADDITIONALLY, WE CONDUCTED A PRACTICAL TEST WITH WATER, COMBINING THE SAMPLE WITH INFUSION SET VL00-XP, BUTCH NUMBER 32261475. DURING THE TESTS, THERE WAS NO FREE FLOW ISSUE OR ANY LEAKAGE. BATCH DOCUMENTATION REVIEW WAS PERFORMED AND FOLLOWING DATA WAS CHECKED: PRODUCTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031787 ↗
• MalfunctionJan 12, 2026Infusion or Flow Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: WHEN WE HOOK A SECONDARY LINE LOT 32261475 TO THE PRIMARY LOT 32213335 ITS NOT PULLING AT ALL, IT'S THE LIKE THE PORT FOR THE PRIMARY ISN'T BEING PUSHED ALL THE WAY IN TO LET THE SECONDARY DRIP. NO ADVERSE EVENT REPORTED 1. REPORTED COMPLAINT MALFUNCTION AREA UNKNOWN 2. QUANTITY OF SAMPLE(S) WE DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION 3. CONCERNED PRODUCT CODE / BATCH INFUSION SET VL SL00-XP, (B)(6) 4. INVESTIGATION REPORT DUE TO THE FACT THAT THERE WAS NO SAMPLES OR PICTURES PROVIDED WE ARE NOT ABLE TO CONFIRM IF THE FAILURE IS RELATED TO THE PRODUCTION PROCESS OR MATERIAL FAULT. BASED ON THE REASON FOR THE COMPLAINT, WE 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, WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND FOUND NO ABNORMALITIES. ADDITIONALLY, WE CONDUCTED A PRACTICAL TEST WITH WATER, COMBINING THE SAMPLE WITH INFUSION SET VL SP40-11, BATCH NUMBER 32213335. DURING THE TESTS, THERE WAS NO FREE FLOW ISSUE OR ANY LEAKAGE. BATCH DOCUMENTATION REVIEW WAS PERFORMED AND FOLLOWING DATA WAS CHECKED: PRODUCTION ORDERS, IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031786 ↗
• MalfunctionJan 12, 2026Infusion or Flow Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: WHEN WE HOOK A SECONDARY LINE LOT 32261475 TO THE PRIMARY LOT 32213335 ITS NOT PULLING AT ALL, IT'S THE LIKE THE PORT FOR THE PRIMARY ISN'T BEING PUSHED ALL THE WAY IN TO LET THE SECONDARY DRIP. NO ADVERSE EVENT REPORTED. 1. REPORTED COMPLAINT - MALFUNCTION AREA UNKNOWN. 2. QUANTITY OF SAMPLE(S) - WE DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION. 3. CONCERNED PRODUCT CODE / BATCH. INFUSION SET VL SP40-11, (M46445475), 32213335. 4. INVESTIGATION REPORT: DUE TO THE FACT THAT THERE WAS NO SAMPLES OR PICTURES PROVIDED WE ARE NOT ABLE TO CONFIRM IF THE FAILURE IS RELATED TO THE PRODUCTION PROCESS OR MATERIAL FAULT. BASED ON THE REASON FOR THE COMPLAINT, WE 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, WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND FOUND NO ABNORMALITIES. ADDITIONALLY, WE CONDUCTED A PRACTICAL TEST WITH WATER, COMBINING THE SAMPLE WITH INFUSION SET VL00-XP, BUTCH NUMBER 32261475. DURING THE TESTS, THERE WAS NO FREE FLOW ISSUE OR ANY LEAKAGE. BATCH DOCUMENTATION REVIEW WAS PERFORMED AND FOLLOWING DATA WAS CHECKED:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031783 ↗
• MalfunctionJan 12, 2026Infusion or Flow Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: WHEN WE HOOK A SECONDARY LINE LOT 32261475 TO THE PRIMARY LOT 32213335 ITS NOT PULLING AT ALL, IT'S THE LIKE THE PORT FOR THE PRIMARY ISN'T BEING PUSHED ALL THE WAY IN TO LET THE SECONDARY DRIP. NO ADVERSE EVENT REPORTED. 1. REPORTED COMPLAINT: MALFUNCTION AREA UNKNOWN. 2. QUANTITY OF SAMPLE(S): WE DID NOT RECEIVE ANY SAMPLE OR PICTURE FOR INVESTIGATION. 3. CONCERNED PRODUCT CODE / BATCH: INFUSION SET VL SL00-XP, (M77460052), 32261475. 4. INVESTIGATION REPORT: DUE TO THE FACT THAT THERE WAS NO SAMPLES OR PICTURES PROVIDED WE ARE NOT ABLE TO CONFIRM IF THE FAILURE IS RELATED TO THE PRODUCTION PROCESS OR MATERIAL FAULT. BASED ON THE REASON FOR THE COMPLAINT, WE 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, WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE SAMPLE AND FOUND NO ABNORMALITIES. ADDITIONALLY, WE CONDUCTED A PRACTICAL TEST WITH WATER, COMBINING THE SAMPLE WITH INFUSION SET VL SP40-11, BATCH NUMBER 32213335. DURING THE TESTS, THERE WAS NO FREE FLOW ISSUE OR ANY LEAKAGE. BATCH DOCUMENTATION REVIEW WAS PERFORMED AND FOLLOWING DATA WAS CHECKED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031776 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121613. 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 be
• 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