i.v.STATION ONCORecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08056477790014), received between Apr 18, 2019 and May 12, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT BETWEEN INJECTING DOSES, PACITAXEL WAS SPILLED BY THE DEVICE. SPECIFICALLY, THE USER RAN 2 PACLITAXEL DOSES OF 25ML (150MG) FOR A TOTAL OF 50ML (300MG) AND IT DREW UP BOTH DOSES USING A 50ML SYR. THE ISSUE CAME UP AFTER IT INJECTED THE FIRST DOSE. WHEN THE NEEDLE WAS PULLED OUT OF THE BAG IT WAS DRIPPING CONTINUOUSLY UNTIL IT PUT THE NEEDLE INTO THE SECOND BAG. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812428 ↗
• MalfunctionMar 23, 2021Material Twisted/Bent; Material Twisted/Bent

  ON (B)(3), THE USER ATTEMPTED TO PREPARE A TOXOL PREPARATION AND THE ROBOT MISSED THE IV BAG. THIS RESULTED IN A TAXOL SPILL (~25ML) WITHIN THE DEVICE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11551547 ↗
• MalfunctionOct 21, 2020Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  ON (B)(6) 2020 TWO SPILLS INVOLVING PACLITAXEL CHEMOTHERAPY DRUG PREPARATIONS OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE DEVICE IDENTIFIED THE SPILLS AND NOTIFIED THE USER WHO SUBSEQUENTLY CLEANED THE SPILLS. THE CAUSE OF THE SPILLS WAS DUE TO MISALIGNMENT BETWEEN THE INJECTION NEEDLE AND BAG PORT; WHEN THE DRUG DOSER ROTATED DOWN THE NON-CENTERED NEEDLE BENT AND PUNCTURED THE WALL OF THE PORT RESULTING IN SPILLAGE. THE SHELF AT THE BAG INJECTION POINT WAS RADIALLY ADJUSTED TO PREVENT MISALIGNMENT AND RECURRENCE OF THIS ISSUE. THERE IS NO ADVERSE PATIENT EFFECT RELATED TO THIS DRUG SPILL WITHIN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10711245 ↗
• MalfunctionMay 16, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION ONCO DEVICE MISLABELED A BAG PREPARATION. THE LABEL CONTAINED ILLEGIBLE CONTENT REGARDING BOTH PATIENT AND DRUG INFORMATION. THE LABEL WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615500 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  ON (B)(6) 2019 A SPILL INVOLVING A CHEMOTHERAPY DRUG PREPARATION OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE SPILL WAS IDENTIFIED BY THE USER FOLLOWING. THERE IS NO KNOWN ADVERSE PATIENT EFFECT RELATED TO THIS DRUG SPILL WITHIN THE DEVICE, HOWEVER, THERE IS A CONCERN REGARDING USER EXPOSURE DURING CLEAN-UP OF THE SPILL. THERE IS ALSO A POTENTIAL OF CROSS-CONTAMINATION IF THE SPILL WAS NOT IMMEDIATELY IDENTIFIED AND CLEANED AND INTERNAL COMPONENTS OF THE DEVICE TRANSFERRED SPILLED DRUG TO OTHER PREPARATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527135 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  ON (B)(6) 2019 A SPILL INVOLVING A CHEMOTHERAPY DRUG PREPARATION OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE SPILL WAS IDENTIFIED BY THE USER FOLLOWING A FAILED PREPARATION. THERE IS NO KNOWN ADVERSE PATIENT EFFECT RELATED TO THIS DRUG SPILL WITHIN THE DEVICE, HOWEVER, THERE IS A CONCERN REGARDING USER EXPOSURE DURING CLEAN-UP OF THE SPILL. THERE IS ALSO A POTENTIAL OF CROSS-CONTAMINATION IF THE SPILL WAS NOT IMMEDIATELY IDENTIFIED AND CLEANED AND INTERNAL COMPONENTS OF THE DEVICE TRANSFERRED SPILLED DRUG TO OTHER PREPARATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527131 ↗