Volumat™ Line VL SP40-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04250273733860), received between Mar 20, 2026 and Mar 20, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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, 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 ↗
• 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 24646756 ↗
• 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 24646755 ↗
• 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 24646754 ↗
• 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 24646753 ↗
• 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 24646752 ↗
• 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 24646751 ↗
• 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 24646750 ↗
• 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 24646749 ↗
• 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 24646748 ↗

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