ICU Medical MC3316Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709037458), received between May 1, 2023 and Nov 25, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS, ROTATING LUER REPORTED THAT THE Y EXTENSION TUBING WAS LEAKING AT SITE OF CAP/TUBING JUNCTION, SO INFUSION TRANSFERRED FROM THAT Y PORT TO OTHER AND TUBING CLAMPED. THEY CHANGED THE Y EXTENSION AT CANNULA HUB WITHOUT ANY DIFFICULTIES. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641000 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS, ROTATING LUER WHERE IT WAS STATED IN THE REPORT AT THE START OF THE SHIFT THAT THERE WAS NO HEALTH CARE ASSISTANT (HCA) ON THE UNIT UNTIL 1500. ADDITIONALLY, THE UNIT WAS DOWN ONE NURSE. THEY CALLED THE PATIENT'S MOTHER AT 0740 TO INFORM HER THAT THERE WAS NO HCA AVAILABLE TO PROVIDE 1:1 CARE. THE PATIENT WAS IN A SHORT-SLEEVED SHIRT WHEN THEY TOOK THEM INTO THEIR CARE. PRIOR TO GOING INTO ANOTHER PATIENT'S ROOM, THEY LOOKED AT THE NURSING STATION TO SEE IF ANY OTHER NURSES WERE AVAILABLE TO WATCH THE PATIENT. THEY CAME BACK INTO THE PATIENTS' ROOM AT 0815 WHEN TOTAL PARENTERAL NUTRITION (TPN) WAS SCHEDULED TO FINISH. PATIENTS WERE SITTING IN THE CHAIR AND STOOD UP; THEY NOTICED BLOOD ON THE PATIENT'S BACK AND ON THE CHAIR AND DRIPS OF BLOOD ON THE FLOOR WHERE THE PATIENT HAD WALKED. THEY WENT INTO THE ROOM AND ASSESSED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WHICH UPON ASSESSMENT WAS STILL INTACT. THE IV LINE RUNNING PN HAD BROKEN AT A HUB AND WAS RUNNING PN ON THE GROUND AND BLOOD WAS BACK FLOWING OUT OF THE PICC ONTO THE PATIENT'S BACKSIDE. THEY IMMEDIATELY CLAMPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328213 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS, ROTATING LUER WHERE IT WAS STATED THAT THE DEVICE HAD LEAKING FROM HUB OF Y-SITE CONNECTED TO PATIENT WHILE INFUSING CHEMOTHERAPY. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317156 ↗
• MalfunctionJun 26, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 7" (18 CM) APPROXIMATELY 0.37 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER WHERE IT WAS REPORTED THE Y SITE ON TOTAL PARENTERAL NUTRITION (TPN) LINE SNAPPED AND TPN BECAME CONTAMINATED. THE IMPACT OF THE INCIDENT WAS HAVING TO PAUSE TPN AND DELAYING NUTRITIONAL NEEDS. THERE WAS UNEXPECTED OR PROLONGED CARE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340679 ↗
• MalfunctionNov 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THE Y-SITE CONNECTOR FOR INTRAVENOUS (IV) TUBING WAS LEAKING. BLOOD WAS BACKING UP FROM A FEMORAL CENTRAL VENOUS LINE (CVL) INTO THE TUBING IV, AND THEN IT WAS NOTED THAT THERE WAS BLOOD ON THE BEDSHEETS. UPON TRACING THE LINES, A LEAK WAS FOUND AT THE BIFURCATION OF A Y-SITE CONNECTOR TUBING. THE IMPACT OF THE INCIDENT WAS A SCANT AMOUNT OF BLOOD LOSS, SMALL AMOUNT OF MEDICATION NOT ADMINISTERED VIA CONTINUOUS INFUSION, INCREASED RISK OF INFECTION. THE NUMBER OF DEFECTIVE DEVICES IS ONE. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694769 ↗
• InjuryMay 1, 2023Material Separation; Material Separation

  THE EVENT INVOLVED A 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER. IT WAS REPORTED THAT THE SALINE LOCK EXTENSION TUBING CONNECTOR PIECE (PLASTIC) SNAPPED OFF. ACCORDING TO THE REPORT ¿SEDATION BECAME DISCONNECTED AT SOME POINT. THE PATIENT WOKE UP. IMPACT OF INCIDENT WAS PATIENT WOKE UP, PATIENT CURRENTLY HAS SPINAL CORD COMPRESSION. PATIENT WAS NOT SUPPOSED TO WAKE UP. COULD HAVE HARMED HIMSELF. THERE WAS UNKNOWN UNEXPECTED OR PROLONGED CARE. THERE WAS NO BLOOD LOSS/BLEED BACK REPORTED. THE PRODUCT WAS USED SINCE PATIENT WAS TRANSFERRED TO THE UNIT ~26-36 HOURS. NEW TUBING WAS ATTACHED AND BOLUS OF SEDATION WAS ADMINISTERED TO RE-SEDATE THE PATIENT. THERE WAS NO REPORT OF ANY FURTHER PATIENT HARM.

  Patient problems: Awareness During Anesthesia

  MAUDE report 16850436 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0228-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709089904(17)250101(30)25(10)4713954.
• Z-0195-2021 · Jul 6, 2020 · Terminated
  109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotati
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• Z-0183-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)
• Z-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• Z-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case
• Z-0199-2021 · Jul 6, 2020 · Terminated
  9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)455847

…and 173 more.