Primary SetsRecalls & reported problems across all models

We found 2 models of Primary Sets by ICU Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2023 and Jun 17, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Primary Sets recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 12, 2026Open, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3160-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported Primary Sets problems

Primary Sets models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Primary Sets B917801

  Set, administration, intravascular
  1 recall1 report
• Primary Sets B912601

  Set, administration, intravascular
  3 reports

Recent Primary Sets adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEH, AND IT WAS REPORTED THAT THE ANTI-REFLUX VALVE IS PERMEABLE, SO NOT FUNCTIONAL. THE INJECTED MEDICATION RISES IN THE SOLUTION AND IS NOT PROPERLY ADMINISTERED TO THE PATIENT. INADEQUATE DOSAGE FOR THE ADMINISTRATION OF MEDICATION, WHICH CAN HAVE HARMFUL CONSEQUENCES FOR THE PATIENT. THERE WERE NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530948 ↗
• MalfunctionSep 27, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A PRIMARY SET, CLAVE Y-SITE, 100 INCH, NON-DEHP WHERE THE CUSTOMER REPORTED THAT THE INFUSION PUMP USED WITH THE SET CONTINUED TO INFUSE AFTER THE BAG OF MEDICATION RAN OUT, INFUSING APPROXIMATELY 5 ML OF AIR INTO THE PATIENT. THE RN ON DUTY WAS ABLE TO USE A SYRINGE TO PULL OUT THE 5 ML OF AIR. ADDITIONALLY, THE CUSTOMER STATED THAT THEY ARE NOT SURE ON WHAT WAS DEFECTIVE. THEY RAN THE PUMP AND THE TUBING SET THROUGH TESTING AND COULDN'T RECREATE THE ISSUE THAT HAPPENED. THE TESTING OF THE PUMP AND TUBING SET ALL PASSED INSPECTIONS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320304 ↗
• MalfunctionDec 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP. THE REPORTED STATED THAT THE TUBING OF THE DEVICE WAS LEAKING. THERE WAS NO HUMAN HARM REPORTED AS A RESULT OF THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314955 ↗
• MalfunctionNov 15, 2023Backflow; Backflow

  THE EVENT INVOLVED A PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP . IT WAS REPORTED A SYRINGE PUMP TUBING WAS CONNECTED TO THE PROXIMAL SITE, WITH PROPOFOL BEING INFUSION. PROPOFOL IMMEDIATELY MOVED UP TO THE SOLUTE. THE TUBING WAS CLAMPED TO MAKE SURE THE MEDICATION WENT TO THE PATIENT. ONCE THE PATIENT WAS INDUCED, INJECTED THE ANTIBIOTIC VIA THE DISTAL SITE, AND THE SAME PROBLEM OCCURRED, I.E. A RETURN TO THE SOLUTE. THE PRIMARY SOLUTE WAS CONNECTED TO A PERIPHERAL PERMEABLE 20 G CHANNEL. HE ADDED THAT THE PROBLEM WAS NOT REPEATED WITH SUBSEQUENT INJECTIONS AND THE CONTINUOUS INFUSION OF PROPOFOL DID NOT FLOW BACK TO THE SOLUTE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140055 ↗

Other ICU Medical, Inc. products

• CADD123 models · 53,012 reports · 21 recalls
• Medfusion16 models · 13,114 reports · 5 recalls
• Bivona469 models · 2,811 reports · 29 recalls
• Level 152 models · 3,733 reports · 1 recall
• Portex409 models · 3,479 reports · 5 recalls
• Cleo6 models · 2,782 reports
• Pneupac23 models · 1,972 reports
• Medex98 models · 774 reports · 23 recalls