ICU Medical AC205Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00887709080010), received between Feb 14, 2019 and Feb 17, 2026 — classified as 1 death, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

4 other recalls cover devices cleared under the same FDA submission (K080077); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Disconnection

  THE EVENT INVOLVED A STOPCOCK 4-WAY 5 GANG WITH BASEPLATE ROTATING LUER AND IT WAS REPORTED THAT THE LUER LOCK ON MANIFOLD BECAME COMPLETELY DISCONNECTED FROM THE NEEDLESS CONNECTOR ON THE PATIENT'S CENTRAL VENOUS CATHETER (CVC) ON TWO OCCASIONS. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock

  MAUDE report 24361794 ↗
• MalfunctionNov 21, 2025Separation Problem; Separation Problem

  THE EVENT WAS REPORTED VIA MEDSUN UF/IMPORTER REPORT # 1402760000-2025-8003 REGARDING A5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER. IT WAS REPORTED THAT A MICROCLAVE THAT HAD NICARDIPINE RUNNING THROUGH THE LINE SNAPPED OFF. THERE WAS NO PULLING OF THE LINES, SO UNKNOWN HOW/WHY THE MICROCLAVE SNAPPED OFF. 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 23620162 ↗
• MalfunctionNov 21, 2025Separation Problem; Separation Problem

  THE EVENT WAS REPORTED VIA MEDSUN UF/IMPORTER REPORT # (B)(4) INVOLVING A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER. THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN SEPTEMBER 2025; 1ST SEPTEMBER 2025 IS BEING USED AS PLACE HOLDER. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN TRANSPORT BACK TO THE INTENSIVE CARE UNIT WHEN A "SNAP" WAS HEARD. NOREPINEPHRINE LINE WAS DISCONNECTED. THE MICROCLAVE ON THE MANIFOLD HAD CRACKED AND SNAPPED IN HALF. 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 23619702 ↗
• MalfunctionOct 20, 2025Crack; No Flow; Crack; No Flow

  THE LUER LOCK OF A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER REPORTEDLY BROKE, AND DISCONTINUED THE FLOW OF UNSPECIFIED LIFE-SUSTAINING MEDICATIONS. THE PATIENT WAS IN TRANSPORT FROM THE CT SCANNER WHEN A SNAP WAS HEARD AND THE NOREPINEPHRINE LINE (THE GTT WAS OFF) WAS DISCONNECTED. THE MICROCLAVE THAT WAS ATTACHED TO THE MANIFOLD WAS SNAPPED IN HALF, EXPOSING A SHARP EDGE AND THERE WAS NO WAY TO RECONNECT THE IV TUBING. WHEN EN ROUTE BACK TO UNIT, A SECOND MICROCLAVE CONNECTED TO RUNNING NICARDIPINE WAS SNAPPED WITHOUT SIGNIFICANT PULLING OF THE LINES, IN THE SAME FASHION. BLOOD WAS BACKING UP IN THE LINE, AND THE PATIENT'S BLOOD PRESSURE WAS MONITORED UNTIL PATIENT RETURNED TO THEIR ROOM AND A NEW NICARDIPINE GTT WAS HUNG. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336347 ↗
• MalfunctionOct 20, 2025Crack; No Flow; Crack; No Flow

  THE LUER LOCK OF 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER REPORTEDLY BROKE, RESULTING IN ABRUPT DISCONTINUATION OF LIFE-SUSTAINING MEDICATIONS. PATIENT ARRIVED FROM THE OPERATING ROOM AND WHEN THE BED WAS PUSHED INTO THE ROOM IT HIT THE MANIFOLD AND THE PORT WHICH HAD THE PRECEDEX INFUSING CRACKED OFF. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336130 ↗
• MalfunctionOct 20, 2025Crack; No Flow; Crack; No Flow

  A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER REPORTEDLY DISCONTINUED THE FLOW OF UNSPECIFIED LIFE-SUSTAINING MEDICATIONS. IT BROKE OFF EASILY EXPOSING THE SHARP INNER PART THAT COULD NOT BE RECONNECTED. THE MANIFOLD AND THE PORT WITH PRECEDEX INFUSING CRACKED OFF AND THE MICROCLAVE THAT WAS ATTACHED TO THE MANIFOLD WAS SNAPPED IN HALF, EXPOSING A SHARP EDGE. THERE WAS NO WAY TO RECONNECT THE IV TUBING. WHEN EN ROUTE BACK TO UNIT, A SECOND MICROCLAVE CONNECTED TO RUNNING NICARDIPINE WAS SNAPPED WITHOUT SIGNIFICANT PULLING OF THE LINES, IN THE SAME FASHION. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335650 ↗
• MalfunctionOct 25, 2024No Flow; No Flow

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE IN AUGUST, A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER WAS FOUND TO HAVE BEEN BROKEN RESULTING IN A LEAK DURING PATIENT USE. IT WAS REPORTED, ¿BROKEN MANIFOLD ON CARDIAC OR PATIENT THAT ARRIVED TO CCU. IV DRUGS WERE NOT INFUSING PROPERLY AND LEAKING ALL OVER THE FLOOR AND PLACING PATIENT AT RISK FOR AIR EMBOLISM AND IT WAS CAUGHT BEFORE HARM REACHED PATIENT THAT HAS A HYPERTENSION.¿ THE EVENT OCCURRED AT THE HOSPITAL USER FACILITY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532258 ↗
• MalfunctionJun 21, 2024Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER EXPERIENCED DISCONNECTION. THE REPORT STATED THAT "THE OTHER INSTANCES OF DISCONNECTION WERE CAUGHT QUICKLY BEFORE ANY ADVERSE ACTION OCCURRED". THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589889 ↗
• MalfunctionJun 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER GENERATED A LEAK DURING USE. IT WAS REPORTED THAT THE ITEM WAS THE 5-PORT MANIFOLD, THE PATIENT WAS MOVED FROM THE OPERATING ROOM (OR) TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) AND ENDED UP HAVING BLOOD PRESSURE CONTROL ISSUES DUE TO ONE OF THE PORTS NOT FUNCTIONING PROPERLY. IT WAS LEAKING MEDICATION FROM AROUND THE SEAL. THE DEPARTMENT REPORTED THAT THEY REATTACHED THE INTRAVENOUS (IV) LINES TO THE PORT AND IT CONTINUED TO LEAK AT THAT TIME THEY CHANGED OUT THE DEFECTIVE PRODUCT WITH A NEW MANIFOLD THAT HAD NO ISSUES. THE PATIENT WAS IN A BLOOD PRESSURE (BP) CRITICAL ZONE FOR APPROXIMATELY 8 MINUTES, BUT NO INJURY OCCURRED AND THE PATIENT IS RECOVERING FROM THE PROCEDURE. THE DEPARTMENT DISCARDED THE DEFECTIVE ITEM UPON REMOVAL AND REPLACEMENT. NO PATIENT HARM WAS NOTED. THERE WAS A PATIENT INVOLVED, BUT NO PATIENT HARM/INJURY.

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534569 ↗
• MalfunctionJun 13, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 5 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER. THE CUSTOMER REPORTED THAT ¿6 PORT IV PADDLE DISCONNECTED FROM PATIENT INTRODUCER ON ITS' OWN. PATIENT WENT WITHOUT IMPORTANT IV MEDICATION FOR SOME UNKNOWN AMOUNT OF TIME. ADDITIONAL INFORMATION WAS RECEIVED STATING "THE PATIENTS' EPI BECAME DISCONNECTED AND THE PATIENTS¿ BLOOD PRESSURE DROPPED TO THE 60¿S SYSTOLIC FOR SEVERAL MINUTES UNTIL THE CHARGE NURSE NOTICED THAT THE GOWN WAS WET AND THE MEDICATION WAS LEAKING AND IV TUBING WAS DISCONNECTED AND IMMEDIATELY RECONNECTED; THIS WAS FROM THEIR CVICU ON POST-OP PATIENT. THE REFERENCE NUMBER IS (B)(4), PROVIDED LOT NUMBER (10)24043003. 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 19532981 ↗
• MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER. THE CUSTOMER REPORTED THAT THE IV TUBING WILL NOT STAY CONNECTED TO THE PORT AND THAT IT WAS LEAKING EPINEPHRINE. IT WAS REPORTED THAT THE STAFF NOTICED THE LEAK QUICKLY AND TOOK PROPER STEPS TO FIX THE PROBLEM. THE CUSTOMER REPORTED THAT USE OF THIS PRODUCT IS FAIRLY LIMITED TO CVICU AND THE HEART TEAM IN OR TO THE BEST OF THEIR KNOWLEDGE. 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 19523340 ↗
• InjuryJun 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA A MEDSUN MANDATORY MEDWATCH REPORT (MDR REPORT #: (B)(4)) THAT A 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER GENERATED A LEAK. ¿FROM STAFF: PATIENT ARRIVED FROM OPERATING ROOM (OR), ABOUT 10 MINUTES AFTER ARRIVAL, MANIFOLD TUBING THAT CARRIED MEDICATIONS TO PATIENT CRACKED AND LEAKED. IV VASOPRESSORS DID NOT INFUSE INTO PATIENT SO NO RESPONSE TO TITRATION. PATIENT IN NEAR ARREST, REQUIRED IV BOLUS OF EPINEPHRINE FOR HYPOTENSION. PUDDLE WITH BLOOD AND FLUID FOUND ON FLOOR. IV VASOPRESSORS WERE THEN GIVEN VIA PERIPHERAL LINE WITH LARGE INCREASE IN BLOOD PRESSURE. BLOOD PRESSURE VERY LABILE AFTER INCIDENT. MANIFOLD CHANGED TO A NEW MANIFOLD.¿ THERE WAS NO DEATH OR SERIOUS INJURY REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19442664 ↗
• DeathSep 1, 2020Inaccurate Delivery; Detachment of Device or Device Component; Inaccurate Delivery; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS COMPLAINT: MEDICAL INTERVENTIONS PROVIDED AS A RESULT OF THE EVENT WERE: CODE BLUE, ACLS/BLS, OPEN CHEST RESUSCITATION EFFORTS WITH CARDIAC MASSAGE AND INTERNAL DEFIBRILLATION LASTING APPROXIMATELY 25 MINUTES AND IV FLUID FOR VOLUME. THE MEDICATIONS INFUSING WERE: EPINEPHRINE 2MG/100ML, INFUSING AT 3MCG/MINUTE OR 9ML/HR.; FENTANYL 2500MCG/250ML, INFUSING AT 50MCG/HR OR 5ML/HR.; INSULIN 100 UNITS/100 ML, INFUSING AT (B)(4) UNITS/HR OR 4 ML/HR.; NOREPINEPHRINE 8MG/250ML, INFUSING AT 12 MCG/MIN OR 22.5ML/HR.; VASOPRESSIN (B)(4) UNITS/100ML, INFUSING AT 0.04 UNITS/MIN OR 12ML/HR.; NORMOSOL AT 10ML/HR. THE SET-UP OF THE DEVICE: THE CUSTOMER REPORTED THAT CARDIAC SURGERY RACKS ARE SET UP PRETTY STANDARD IN PRE OP. ALL IV MEDS RUN THROUGH A SINGLE ACCESS POINT UNLESS INCOMPATIBLE. EXAMPLES THAT ARE FREQUENTLY INCOMPATIBLE ARE AMIODARONE AND BICARBONATE. A TYPICAL SET UP HAS A PRIMARY IV TUBING LINE THAT CONNECTS TO A MANIFOLD THAT IS TAPED TO THE IV RACK. THIS IS THEN CONNECTED VIA CONNECTION TUBING TO ANOTHER MANIFOLD THAT IS CONNECTED TO A CENTRAL LINE, A SWAN-GANZ LINE. ALL MEDS ARE CONNECTED TO THOSE MANIFOLDS. TYPICALLY, THE PRESSORS

  Patient problems: Cardiogenic Shock; Death; Respiratory Failure

  MAUDE report 10477468 ↗
• MalfunctionAug 12, 2020Material Separation; Material Separation

  THE EVENT INVOLVES AN AC205, 5 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER THAT THE CUSTOMER REPORTED THE MULTIPLE LUER LOCK CONNECTIONS BROKE OFF AFTER A CORONARY ARTERY BYPASS GRAFT. THE CUSTOMER MENTIONED THAT ONE OF THESE PORTS HAD EPINEPHRINE INFUSING WHICH NEGATIVELY IMPACTED THE PATIENT AFTER THE FAILURE OF THE LUER LOCK AND THE PATIENT WAS STABILIZED. THERE WAS PATIENT INVOLVEMENT WITH AN UNSPECIFIED ADVERSE EVENT AND UNSPECIFIED PATIENT HARM ALONG WITH A DELAY IN THERAPY; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; Underdose

  MAUDE report 10395785 ↗
• MalfunctionSep 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE HAD A MANIFOLD FAILURE THAT OCCURRED IN A PATIENT ROOM AND RESULTED IN A SPILL OF IFOSFAMIDE. THE SPILL WAS ON THE FLOOR BETWEEN THE BATHROOM AND BED. THERE WAS A DELAY IN THERAPY AS THE AMOUNT OF CHEMO REMAINING HAD TO BE CALCULATED, ORDERS WRITTEN, DOUBLE SIGNED, RELEASED AND CHEMOTHERAPY REMADE. THERE WAS NO DIRECT HARM.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 8966846 ↗
• MalfunctionFeb 14, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE, ROTATING LUER WHERE THERE WAS REPORTED INTEGRATED CLAVE FAILURES ON THE 5 PORT MANIFOLDS, WHICH RESULTED IN A SIGNIFICANT SPILL OF CISPLATIN. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HARM. THIS REPORT CAPTURES THE SECOND OF TWO OCCURRENCES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 8338848 ↗
• MalfunctionFeb 14, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE, ROTATING LUER WHERE THERE WAS REPORTED INTEGRATED CLAVE FAILURES ON THE 5 PORT MANIFOLDS, WHICH RESULTED IN A SIGNIFICANT SPILL OF CISPLATIN. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HARM. THIS REPORT CAPTURES THE FIRST OF TWO OCCURRENCES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 8338845 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080077. One submission often covers many models, so check the product and lot details in each record.

• Z-0220-2021 · Jul 6, 2020 · Terminated
  Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887
• Z-0250-2021 · Jul 6, 2020 · Terminated
  Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical Clave Stopcock is a device used to administe
• Z-0213-2021 · Jul 6, 2020 · Terminated
  2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)24
• Z-0212-2021 · Jul 6, 2020 · Terminated
  NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medical Clave Stopcock is a device us