ICU Medical 011-MC3316Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840619043230), received between Jun 14, 2022 and Nov 19, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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.

• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER WHERE THE CUSTOMER REPORTED WHILE THE PATIENT WAS BEING ADMINISTERED CISPLATIN, THE DRUG BEGAN TO LEAK FROM THE REAR LUER CONNECTOR ON THE EXTENSION TUBE CONNECTED TO THE CATHETER. THE CUSTOMER STATED THAT THE SPILL PROTOCOL WAS ACTIVATED IMMEDIATELY. IT WAS ALSO REPORTED THAT THE SILICONE HAD SHRUNK, BUT NO PROBLEMS WERE DETECTED WHEN CONNECTING IT. ONLY AFTER DISCONNECTING THE MEDICATION FLOWING THROUGH THAT TUBE DID THE SERUM FLOWING THROUGH THE OTHER TUBE BEGIN TO FLOW BACK THROUGH IT. THERE WAS A DELAY IN THERAPY, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596099 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN EMAIL WAS RECEIVED REGARDING A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT WHILE THE PATIENT'S ADMINISTRATION LINE WAS BEING FLUSHED WITH SALINE SOLUTION, THEY COMPLAINED BECAUSE THEY FELT MOISTURE. THE CUSTOMER OBSERVED THAT THE SALINE WAS LEAKING FROM THE OTHER CONNECTOR OF THE BIFURCATED EXTENSION, WHICH WAS NOT CLAMPED AND WAS NOT CONNECTED, AND THE CONNECTOR HAD THE SILICONE RETRACTED BACKWARDS. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595948 ↗
• MalfunctionMay 28, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS, ROTATING LUER THAT EXPERIENCED CRACK AND LEAKAGE. THIS IS REPORT 2 OF 2 FOR THE UNKNOWN DATE IN (B)(6). THE REPORTER STATED THAT " THE ADULT GENERAL ICU AT BRISTOL ROYAL INFIRMARY USE THE 6 INCH (15CM) SMALLBORE BIFUSE EXTENSION SETS WITH 2 MICROCLAVE CLEAR ADAPTORS AND 3 CLAMPS WITH ROTATING LUER LOCK PRODUCT REF 011-MC-3316. THEY HAVE HAD X2 OF THESE ADAPTORS CRACKED AND LEAKING BELOW THE MICROCLAVE ADAPTOR AT THE ACTUAL LUMEN OF THE LINE- THESE WERE NEW ADAPTORS AND FOUND TO BE LEAKING REPORTED TO MHRA THIS EVENING AS X2 FAILED ADAPTORS FOUND IN THE LAST WEEK- BATCH NUMBER /LOT 14153009. THIS IS A HIGH-RISK EVENT AS AN ICU WE ADMINISTER LIFE PRESERVING AND SAVING MEDICATIONS THROUGH THESE ADAPTORS AND IT IS VERY UNUSUAL TO HAVE HAD TWO ADAPTORS FAIL AT THE SAME POINT IN THE LAST WEEK ¿. UPDATE: THE INCIDENT HAPPENED ON (B)(6) 2025. THIS IS A HIGH-RISK WITH THE CONNECTORS AS CRITICAL MEDICATIONS NOT ADMINISTERED- DUE TO A SPLIT IN THE MATERIAL. THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT HARM BUT POTENTIAL FOR LIFE SAVING MEDICATIONS TO LEAK OUT AND NOT BE ADMI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100303 ↗
• MalfunctionMay 28, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS, ROTATING LUER THAT EXPERIENCED CRACK AND LEAKAGE. THIS IS REPORT 1 OF 2 FOR THE KNOWN DATE OF (B)(6) 2025. THE REPORTER STATED THAT " THE ADULT GENERAL ICU AT BRISTOL ROYAL INFIRMARY USE THE 6 INCH (15CM) SMALLBORE BIFUSE EXTENSION SETS WITH 2 MICROCLAVE CLEAR ADAPTORS AND 3 CLAMPS WITH ROTATING LUER LOCK PRODUCT REF 011-MC-3316. THEY HAVE HAD X2 OF THESE ADAPTORS CRACKED AND LEAKING BELOW THE MICROCLAVE ADAPTOR AT THE ACTUAL LUMEN OF THE LINE- THESE WERE NEW ADAPTORS AND FOUND TO BE LEAKING REPORTED TO MHRA THIS EVENING AS X2 FAILED ADAPTORS FOUND IN THE LAST WEEK- BATCH NUMBER /LOT 14153009. THIS IS A HIGH-RISK EVENT AS AN ICU WE ADMINISTER LIFE PRESERVING AND SAVING MEDICATIONS THROUGH THESE ADAPTORS AND IT IS VERY UNUSUAL TO HAVE HAD TWO ADAPTORS FAIL AT THE SAME POINT IN THE LAST WEEK ¿. UPDATE: THE INCIDENT HAPPENED ON (B)(6) 2025. THIS IS A HIGH-RISK WITH THE CONNECTORS AS CRITICAL MEDICATIONS NOT ADMINISTERED- DUE TO A SPLIT IN THE MATERIAL. THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT HARM BUT POTENTIAL FOR LIFE SAVING MEDICATIONS TO LEAK OUT AND NOT BE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100134 ↗
• MalfunctionMay 7, 2025Break; Break

  A COMPLAINT WAS RECEIVED REGARDING A 6" (15CM) SMALLBORE BIFUSE EXT SET W/2 CLAVE¿ CLEAR, 3 CLAMPS, SPIN LUER, THAT EXPERIENCED BREAKAGE DURING PATIENT USE. THE REPORTER STATED THAT DURING THE NIGHT, THE CATHETER BROKE ACCIDENTALLY. THE SET WAS BEING USED ON A 15-YEAR-OLD FEMALE PATIENT, WITH A CADD SOLIS VIP PUMP AND BLINATUMOMAB MEDICATION WAS BEING ADMINISTERED. TWO PICTURES WERE PROVIDED BY THE CUSTOMER, AND THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THERE WAS DELAY IN CRITICAL THERAPY, ALTHOUGH THERE WAS NO REPORTED HARM. LOLIVEIRA 10-APR-2025 UPDATE: GCM RECEIVED AN EMAIL ON 11-APR-2025 FROM THE ICU MEDICAL SALES REPRESENTATIVE CONFIRMING THAT THE HOSPITAL COULD NOT VERIFY THE LOT NUMBER OF THE PRODUCT INVOLVED IN THE EVENT. LOLIVEIRA 11-APR-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981365 ↗
• MalfunctionMar 20, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER THAT EXPERIENCED NO FLOW. THE CUSTOMER REPORTED MALFUNCTIONS IN THE FUNCTIONING OF THE TWO AND THREE-WAY MICRO CLAVE EXTENSION, WHICH MANIFESTS ITSELF AS HEMODYNAMIC INSTABILITY OF THE PATIENT AND THE ERROR MESSAGE ¿ ¿OCCLUSION ON THE PERFUSOR¿. WHEN THE EXTENSION IS REPLACED, THE PATIENT'S CONDITION NORMALIZES. THE PROBLEM HAS OCCURRED IN SEVERAL CASES (UNSPECIFIED QUANTITY). THE EVENT OCCURRED DURING INFUSION. NO SERIOUS INJURY OR DEATH. NO BLOOD LOSS AND NO UNPROTECTED CHEMO EXPOSURE. THERE WAS DELAY IN CRITICAL THERAPY. NO ADVERSE OPERATOR CONSEQUENCES AND NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THE PRODUCT IS STORED IN THE STORAGE AREA, MONITORED AND HAS ALL THE NECESSARY CERTIFICATIONS (ISO STANDARDS ETC.) THERE WERE NO CUTS, HOLES, DEFECTS NOTED ON THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652279 ↗
• MalfunctionMay 25, 2023Disconnection; Disconnection

  THE EVENT INVOLVED A 16" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER. IT WAS REPORTED THAT A DISCONNECTION HAD OCCURRED BETWEEN THE BIOCONNECTOR AND THE BRAUN TREE, WHILE DOCETAXEL WAS BEING ADMINISTERED, GENERATING A CYTOTOXIC SPILL ON THE PATIENT'S SKIN. THE EVENT OCCUR DURING PATIENT USE, THERE WAS A DELAY IN THERAPY, HOWEVER NO ONE WAS HARMED AS A RESULT OF THIS EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005537 ↗
• MalfunctionMay 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXTENSION SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER. IT WAS REPORTED THE MICROCLAVE WAS FOUND TO BE LEAKING NORADRENALINE FROM THE SCREW THREAD WELD ON ISOLATED DEVICES. TESTING ON SAMPLES FROM THE SAME BATCH FOUND THE LEAKS WERE NOT REPEATABLE. THE LEAKS OCCURRED IN TWO DEVICES FROM TWO SEPARATE BATCHES WHERE NO HOLE, CUT, TEARS OR ANY DEFECTED NOTED. THERE WAS NO REPORT OF HARM. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986454 ↗
• MalfunctionMay 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXTENSION SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER. IT WAS REPORTED THE MICROCLAVE WAS FOUND TO BE LEAKING NORADRENALINE FROM THE SCREW THREAD WELD ON ISOLATED DEVICES. TESTING ON SAMPLES FROM THE SAME BATCH FOUND THE LEAKS WERE NOT REPEATABLE. THE LEAKS OCCURRED IN TWO DEVICES FROM TWO SEPARATE BATCHES WHERE NO HOLE, CUT, TEARS OR ANY DEFECTED NOTED. THERE WAS NO REPORT OF HARM. THIS IS THE FIRST OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986451 ↗
• MalfunctionMar 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXTENSION SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER. THE REPORTER STATED THAT THE MICROCLAVE WAS FOUND TO BE LEAKING NORADRENALINE FROM THE SCREW THREAD ON ISOLATED DEVICES. TESTING ON SAMPLES FROM THE SAME BATCH BY THE CUSTOMER FOUND THAT THE LEAKS WERE NOT REPEATABLE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565106 ↗
• MalfunctionJun 14, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DISTAL LUER CONNECTION OF A BRAUN DEVICE DISCONNECTED FROM THE MICROCLAVE, WHICH WAS CONNECTED TO THE PATIENT AND ADMINISTERING PACLITAXEL AND PHYSIOLOGICAL SERUM. DUE TO THE DISCONNECTION THE DRUG SPILLED ON THE FLOOR, ON THE PATIENT'S CHAIR AND ON THE PATIENT. AN INFUSOMAT TREE, FROM B.BRAUN, WAS USED WITH THE PRODUCT. THE EVENT OCCURRED DURING PATIENT USE, HOWEVER, THERE WAS NO DELAY IN THERAPY, NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685814 ↗

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-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• Z-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0
• Z-0226-2021 · Jul 6, 2020 · Terminated
  112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)108
• 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
• Z-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• Z-0188-2021 · Jul 6, 2020 · Terminated
  10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouche
• Z-0224-2021 · Jul 6, 2020 · Terminated
  3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50

…and 173 more.