ICU Medical MC3302Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887709037267), received between Nov 13, 2018 and May 6, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Separation

  AN EMAIL WAS RECEIVED REGARDING AN 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET WITH MICROCLAVE¿ CLEAR, CLAMP, ROTATING LUER WAS ABLE TO PULL ON AN INTRAVENOUS (IV) CONNECTOR BY AN ANIMATED CHILD, WHICH LED TO DEVICE FAILURE. THE WELDED INJECTION VALVE SEPARATED FROM THE TUBING AND ALLOWED BLEEDING. THE CONNECTOR WAS REPLACED AND THE IV WAS NOT DISLODGED. THERE WAS NO DELAY IN THERAPY. THE PRODUCT WAS CONTAMINATED WITH BLOOD. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25107333 ↗
• MalfunctionFeb 10, 2026Backflow; Fluid/Blood Leak

  AN EVENT INVOLVING A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, CLAMP, ROTATING LUER REPORTED THAT UPON RECONNECTION TO THE PATIENT, THE EXTENSION SET DIRECTLY ATTACHED TO THE ARTERIAL LINE NOTED TO BE BACK FILLING. MONITORED AND CHECKED CONNECTION. AFTER A FEW MINUTES, LINE CONTINUED TO BACK FILL AND LEAK. CLAMPED LINE, REMOVED AND REPLACED WITH A NEW EXTENSION SET. NO FURTHER LEAKING OR BACK FILLING NOTED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301616 ↗
• MalfunctionMar 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, CLAMP, ROTATING LUER WAS FOUND TO HAVE GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THE PATIENT WAS RECEIVING INTRAVENOUS ABDOMEN (IV ABD) VIA A SYRINGE PUMP WHEN THE ANTIBIOTICS (ABX) DOSE WAS COMPLETED, THE WRITER WENT IN TO START FLUSHING AND NOTICED A SMALL AMOUNT OF BLOOD ON THE SHEET AROUND THE HUB OF THE SYRINGE PUMP TUBING AND PERIPHERAL INTRAVENOUS CATHETER (PIV). STAFF TRIED TO TIGHTEN SAME AND WAS ALREADY TIGHT. BLOOD WAS STILL DRIPPING OUT AT THE BACK OF THE LURE LOCK ASSEMBLY. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585445 ↗
• MalfunctionMar 11, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT TUBING CHANGE FOR THE LEFT RADIAL PAL WAS DUE AND THE CUSTOMER CLAMPED THE FUSED EXTENSION PIECE AND DISCONNECTED THE OLD TUBING. AFTER SWABBING, THE USER CONNECTED THE NEW TUBING AND UNCLAMPED FUSED EXTENSION PIECE. THE CUSTOMER ZEROED ARTERIAL LINE AND CHECKED THAT ALL THE CONNECTIONS WERE TIGHT AND IT WAS CONFIRMED THAT THEY WERE. AFTER CHARTING THE ACTION, THE USER CHECKED TO SEE IF ANY BLOOD BACKED UP SINCE THE TUBING CHANGE (THIS WAS DONE WITHIN A FEW MINUTES OF THE CHANGE) AND NOTED THAT SOME BLOOD HAD BACKED UP. THE CUSTOMER DREW UP A HEPARIN FLUSH AND WENT TO THE SIDE OF THE BED CLOSEST TO THE LINE TO FLUSH THE PAL. UPON CLOSER INSPECTION THE CUSTOMER NOTICED THAT BLOOD WAS BACKED UP AND LEAKING FROM THE FUSED CAP. THE FUSED EXTENSION PIECE ITSELF SEEMED TO BE DAMAGED, OR THE CAP ITSELF WAS MALFUNCTIONAL, LEADING TO BLOOD BACK UP AND BLOOD LEAKING ONTO THE BED. THE CUSTOMER CLAMPED THE FUSED EXTENSION PIECE AND PAGED THE PICC RN. WITH THE PICC RN, THEY MANUALLY OCCLUDED THE ARTERY SO THAT THE EXTENSION PIECE COULD BE SWITCHED OUT FROM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580101 ↗
• MalfunctionMar 6, 2025Crack; Fluid/Blood Leak; Material Split, Cut or Torn; Crack; Fluid/Blood Leak; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED ON 10-FEB-2025 STATING THAT, THE MICROCLAVE FUSED CAP EXTENSION PIECE WAS PRIMED PRIOR TO ATTACHING IT TO THE ARTERIAL CATHETER AFTER INSERTION. IT WAS THEN USED TO DRAW A BLOOD SAMPLE USING A LUER LOCK SYRINGE. NO COMPLICATIONS WERE NOTED WHEN DRAWING THE SAMPLE. HOWEVER, WHEN THE FLUSH WAS ATTACHED TO CLEAR THE BLOOD IN THE EXTENSION PIECE, LEAKING WAS NOTED IN THE HUB AND AT THE CONNECTION BETWEEN THE FUSED CAP AND THE BORE OF THE TUBING. NO DEVIATION FROM STANDARD LINE PRACTICES WERE IDENTIFIED. THE EXTENSION SET WAS ATTACHED TO THE IV CATHETER ON ONE END AND TWO SYRINGES WERE ATTACHED AND REMOVED VIA THE LUER MECHANISM ON THE CAP END PRIOR TO THE DEFECT BEING IDENTIFIED. NO HARM TO THE INFANT AS THE DEFECT WAS NOTICED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541020 ↗
• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, CLAMP, ROTATING LUER. IT WAS REPORTED IV (INTRAVENOUS) WAS FOUND LEAKING IV FLUID IN BED. LOOKED AT CONNECTIONS AND FOUND THAT THE SMALL BORE EXT SET W/MICROCLAVE CLEAR (MC3302) WAS WHERE THE LEAKING WAS COMING FROM. THE RUBBER STOPPER MUST HAVE BEEN BROKEN AS FLUID WAS POOLING BEHIND THE RUBBER PART. PART IMMEDIATELY CHANGED OUT. IT WAS THE CONNECTION TO THE NICU PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190595 ↗
• MalfunctionSep 26, 2024No Flow; No Flow

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER. THE REPORT STATED THAT HAD AN INCIDENT WITH A STUCK DOWN CLAVE, THIS TIME WITH A LARGER BORE PICC CATHETER. IT CAUSED A COMPLETE BLOCK OF FORWARD FLOW OF FLUID, VERIFIED BY THE BEDSIDE NURSE ATTEMPTING TO FLUSH MANUALLY THROUGH THE MICROCLAVE. THE REPORTED ADDED THAT THE PICC LINE HAS OCCLUDED SO THE PATIENT WILL NEED A NEW PICC LINE IF THEY CANNOT CLEAR THE OCCLUSION. THE MEDICATION BEING INFUSED WERE TPN/LIPIDS, CAFFEINE, AND ANTIBIOTICS. PREVANTICS WAS BEING USED AND THE SET BEEN IN USE FOR 36 HOURS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310125 ↗
• InjuryAug 8, 2024No Flow; No Flow

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER WAS FOUND TO BE OCCLUDED DURING PATIENT USE. THE INCIDENT INVOLVED THE PRODUCT BEING CONNECTED TO THE VYGON 1FR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE (THE SMALLEST CATHETER THAT THEY USE) WHICH WAS REMOVED DUE TO SUSPICION OF IMPAIRED FORWARD FLOW OF FLUID THROUGH THE MICROCLAVE. WHEN THE INFUSION TUBING WAS FIRST DISCONNECTED FROM THE BONDED MICROCLAVE, THE MICROCLAVE SEPTUM WAS NOTED TO BE STUCK IN THE ENGAGED/DEPRESSED POSITION. NO OTHER CRACKS OR LEAKING ALONG THE EXTENSION SET WERE NOTED. WHEN THE EXTENSION SETS WERE REPLACED WITH NEW ONES, FORWARD FLOW WAS CONFIRMED BY CLINICAL STAFF, AND IMPROVEMENT IN THE PATIENT'S STATUS (LOW BLOOD SUGAR) WAS NOTED. THEY HAVE ONLY NOTED THIS ISSUE WITH THEIR 1FR PICC CATHETER WHICH IS NOT WIDELY USED.

  Patient problems: Hypoglycemia

  MAUDE report 19945714 ↗
• InjuryAug 8, 2024No Flow; No Flow

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER WAS FOUND TO BE OCCLUDED DURING PATIENT USE. THE INCIDENT INVOLVED THE PRODUCT BEING CONNECTED TO THE VYGON 1FR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE (THE SMALLEST CATHETER THAT THEY USE) WHICH WAS REMOVED DUE TO SUSPICION OF IMPAIRED FORWARD FLOW OF FLUID THROUGH THE MICROCLAVE. WHEN THE INFUSION TUBING WAS FIRST DISCONNECTED FROM THE BONDED MICROCLAVE, THE MICROCLAVE SEPTUM WAS NOTED TO BE STUCK IN THE ENGAGED/DEPRESSED POSITION. NO OTHER CRACKS OR LEAKING ALONG THE EXTENSION SET WERE NOTED. WHEN THE EXTENSION SETS WERE REPLACED WITH NEW ONES, FORWARD FLOW WAS CONFIRMED BY CLINICAL STAFF AND IMPROVEMENT IN THE PATIENT'S STATUS (LOW BLOOD PRESSURE) WAS NOTED. THE CLINICAL NURSE EDUCATOR WAS PRESENT AND COULD VOUCH THAT THE ¿STUCK¿ SEPTUM WAS RELEASED WHEN SHE ATTACHED AND DISCONNECTED A FLUSH SYRINGE, BUT THEY CHANGED OUT THAT EXTENSION SET JUST TO BE CAREFUL. THEY HAVE ONLY NOTED THIS ISSUE WITH THEIR 1FR PICC CATHETER WHICH IS NOT WIDELY USED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19945612 ↗
• MalfunctionJun 14, 2023Particulates; Particulates

  THE INCIDENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER. IT WAS REPORTED THERE WAS A BROWN LIKE PARTICLE IN THE TUBING. THERE WAS NO UNEXPECTED OR PROLONGED CARE HAPPENED. THE PROBLEM HAPPENED FOR THE FIRST TIME AND INVASIVE PROCEDURE IS NOT PROVIDED OR NOT APPLICABLE. DEFECT-DETECTED BEFORE USE TYPE OF INCIDENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17129514 ↗
• MalfunctionNov 13, 2018Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  THE EVENT INVOLVES A CUSTOMER ALLEGATION AGAINST A SMALLBORE EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER THAT LEAKED WHILE THE CLINICIAN WAS DISCONNECTING THE PATIENT FROM THE IV LINE. WHILE FLUSHING THE LINE, THE PATIENT COMMENTED IT WAS LEAKING. THE CLINICIAN CONFIRMED THE PUMP WAS OFF AND NOTED THE CAP HAD PULLED OFF THE TUBING OF THE SALINE LOCK. IT WAS NOTED THAT BLOOD HAD STARTED FLOWING OUT OF THE SALINE LOCK. THE CLAMP ON THE DEVICE WAS CLOSED AND WAS REPLACED WITH A NEW DEVICE PRIMED WITH SALINE. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8066623 ↗

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-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-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-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-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-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
• Z-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0203-2021 · Jul 6, 2020 · Terminated
  8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30
• Z-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• Z-0214-2021 · Jul 6, 2020 · Terminated
  99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515
• 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-0196-2021 · Jul 6, 2020 · Terminated
  7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)2

…and 173 more.