ICU Medical MC9013Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887709039391), received between Sep 15, 2020 and Sep 11, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Backflow

  The event involved 14" Ext Set with 0.2 Micron Filter, Clave Clear, Clamp, Rotating Luer. It was reported that the patient placed supine to boost up in bed for scheduled CXR. After patient was sat back up, blood noted to have backed up from the CVC into the medication and vasopressor lines (there was a filter attached to the line). Patient became hypotensive, additional vasopressors administered and patient stabilized. It appears that lines with the filter attached were more prone to this issue. The event occurred during infusion. There was a patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729772 ↗
• MalfunctionMay 14, 2026Crack; Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING 14" EXT SET W 0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER IN WHICH IT WAS REPORTED THAT WHEN A MICRON FILTER (0.22) WAS PRIMING WITH SALINE TO THE PATIENT - THE PATIENT NOTICED FLUID WAS LEAKING FROM THE RECTANGULAR FILTER ONTO HER BEDSIDE TABLE. INFUSION WAS STOPPED AND IT WAS NOTED THAT THERE WAS A LEAK AND/OR SMALL CRACK IN THE CARTRIDGE. THERE WERE A PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166863 ↗
• MalfunctionMay 12, 2026No Flow

  AN EMAIL WAS RECEIVED REGARDING 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER IN WHICH IT WAS REPORTED THAT THE PATIENT WAS ON A LARGE AMOUNT OF PRESSORS, AND THE BLOOD PRESSURE DROPPED DUE TO NO FLOW. THE INITIAL REPORTER STATED: THE PLAN WAS TO WAIT FOR FAMILY TO CHANGE GOC [ABBREVIATION NOT SPECIFIED]. REGISTERED NURSE NOTED THAT THE LINE WAS BACKING UP WITH BLOOD PAST THE FILTER AND PATIENT'S BLOOD PRESSURE WAS DROPPING. REGISTERED NURSE REPLACED THE STOP COCK, AND THE EXTENSION TUBING (WITH FILTER) AND THE PATIENT'S BLOOD PRESSURE WAS IMPROVED. REGISTERED NURSE NOTICED A PIECE OF PLASTIC STUCK IN THE STOP COCK THAT PRESUMABLY BROKE OFF THE EXTENSION SET TWO DEVICES. THE EVENT OCCURRED DURING INFUSION. THERE WAS A PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25153503 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE REPORT STATES THAT THEY WERE INFUSING PACLITAXEL WHEN THEY NOTICED A LEAK. IT WAS ALSO REPORTED THAT THE DOSE WAS A 24-HOUR INFUSION OF PACLITAXEL, WITH A CONCENTRATION AROUND 0.8MG/ML. IT APPEARED THAT THE LEAKING OCCURRED LATER ON DURING THE INFUSION, ACCORDING TO PATIENT ACCOUNTS. ADDITIONALLY, IT WAS REPORTED THAT THE DOSE STARTED AT (B)(6) 2024, 18:33. ON (B)(6) 2024, ABOUT 4 PM, THE PATIENT WAS SITTING IN THE CHAIR ON THEIR COMPUTER AND NOTICED A WET STAIN ON THEIR GOWN. THE FILTER WAS LEAKING FROM A DIVOT. THE NURSES CAME TO REPLACE AND CLEAN THE AREA. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323168 ↗
• MalfunctionJan 15, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2025 AND INVOLVED A 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER. IT WAS REPORTED THAT LIQUID WAS ON THE FLOOR, AND A LEAK OF CHEMOTHERAPY WAS NOTICED ALONG THE PRIMARY TUBING, AT THE FILTER AREA. THE SPILL RAN UNDER AND BEHIND THE CHAIR WHERE PATIENT WAS SITTING. NONE OF THE CHEMOTHERAPY LEAKED ON TO THE PATIENT. INFUSION WAS STOPPED, PATIENT DISCONNECTED AND MOVED TO ANOTHER AREA. SPILL <500ML WAS CLEANED BY PHARMACY PER PROTOCOL. PATIENT EVENTUALLY RESTARTED WITH ANOTHER BAG OF CHEMO. EVENT OCCURRED AT AN OUTPATIENT TREATMENT FACILITY. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24088713 ↗
• MalfunctionJun 7, 2025Leak/Splash; Leak/Splash

  THE EVENT INVOLVED A 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER WHERE THE REPORTER STATED THAT WHEN DOING ¿IDC¿ (UNDERSTOOD TO BE INVASIVE DUCTAL CARCINOMA) DROPLETS WERE SEEN COMING FROM THE MICRON FILTER ON THE LOWER RIGHT-HAND SIDE. THE CUSTOMER STATED THAT THE HEALTHCARE PROFESSIONAL PUT ON PERSONAL PROTECTIVE EQUIPMENT (PPE) AND TREATED AS CHEMO SPILL. THE PATIENT HAD ONE DROPLET ON SHIRT AND CHANGED INTO A HOSPITAL SHIRT. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY, BUT THERE WAS NO HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 22163430 ↗
• MalfunctionMay 21, 2025Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE REGISTERED NURSE (RN) WENT TO HOOK PATIENT UP TO IV LINE WITH FILTER, PATIENT NOTICED A LARGE AIR BUBBLE COMING FROM FILTER. THE IV LINE WAS DISCONNECTED THREE TIMES TO REMOVE AIR AND FILTER KEPT PRODUCING AIR BUBBLES. DUE TO THE PATIENT HAVING A HISTORY OF HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT), IT IS PROTOCOL FOR INFUSIONS TO HAVE A FILTER PUT ON IV SET TO PREVENT AIR FROM ENTERING BLOOD STREAM. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061952 ↗
• MalfunctionMar 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER. THE REPORTER STATED THAT, DURING INJECTION OF A RADIOACTIVE TRACER DURING THE STRESS PORTION OF A MYOCARDIAL PERFUSION IMAGING (MPI STRESS) TEST, THE PATIENT'S PATENT FORAMEN OVALE (PFO) FILTER MALFUNCTIONED AND RUPTURED. UNSPECIFIED TRACER LEAKED AND LANDED ON THE ECG TECH AND THE PATIENT. ALL INVOLVED AND THE AREA NEEDED TO BE DECONTAMINATED AND THE PATIENT NEEDED TO HAVE THE PROCEDURE REDONE. THE LEAK WAS RIGHT AT THE RECTANGLE OF THE FILTER. THERE WAS UNEXPECTED OR PROLONGED CARE. THERE WAS NO REPORT OF ANY SPECIFIC HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 21607649 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED INVOLVING A 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE. THE PROBLEM WAS: LEAKING FILTER IN THE ONCOLOGY UNIT. IT WAS EXPLAINED THAT A SECOND IDENTICAL INCIDENT OCCURRED WITH MC9013 DURING CHEMO ADMINISTRATION WITH THE SAME PATIENT ON OCTOBER 20 (PREVIOUSLY HAPPENED ON 18 OCTOBER). BOTH AFFECTED FILTERS WERE DISCARDED. THEY HAVE REMOVED ALL FILTERS WITH LOT # 13893262 FROM THE HEMATOLOGY-ONCOLOGY UNIT. THE SET UP WAS: MC9013 WAS ADDED TO THE USUAL PRIMARY TUBING (BBRAUN (B)(4)- THEIR ¿CHEMO LINE¿. THE END OF MC9013 WAS ATTACHED TO THE LOWEST Y PORT ON THE USUAL PRIMARY TUBING (BBRAUN (B)(4) - THEIR ¿MAINLINE¿ FOR HYDRATION. THERE WAS NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. SHE HAS A COUPLE SAMPLES SISTER FROM THE SAME LOT NUMBER AVAILABLE FOR EVALUATION. SHE PROVIDED 1 SAMPLE PHOTO FROM THE 18 OCTOBER INCIDENT. THE SAMPLE PHOTO SHOWED FINGERS HOLDING THE FILTER WITH LIQUID LEAK AND LIKE A WHITE CLOTH WITH LEAK ON. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. (B)(6) 23 OCTOBER 2024

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754313 ↗
• MalfunctionNov 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER, WHERE IT WAS REPORTED THE ONCOLOGY UNIT REPORTED AN INCIDENT WITH LEAKING FILTER, WHICH RESULTED IN A MISSED DOSE PORTION IN THE TREATMENT OF CHEMOTHERAPY. THE INFUSION WAS A MIX OF DOXORUBICIN, VINCRISTINE, ETOPOSIDE. THERE WERE MULTIPLE ORANGE (COLOR OF CHEMO) SPOTS FOUND ON SHEET & PIQUE, DISCOVERED IN THE MORNING OF OCTOBER 18, FILTER LOOKED WET AND LEAKING, TUBING ITSELF AND CONNECTIONS NOT LEAKING. THE QUANTITY REMAINING IN THE BAG AND TUBING (ABOUT 7% OF THE DOSE) WAS NOT ADMINISTERED. THE TUBING WAS DISCARDED. AN UPDATE FROM THE CUSTOMER ON (B)(6) 2024 STATED THAT THEY HAVE REMOVED ALL FILTERS WITH LOT#: 13893262 FROM THE HEMATOLOGY-ONCOLOGY UNIT. THE SET UP WAS: MC9013 WAS ADDED TO THE USUAL PRIMARY TUBING (BBRAUN 363430)- THEIR ¿CHEMO LINE¿. THE END OF MC9013 WAS ATTACHED TO THE LOWEST Y PORT ON THE USUAL PRIMARY TUBING (BBRAUN 363430) - THEIR ¿MAINLINE¿ FOR HYDRATION. NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668192 ↗
• MalfunctionOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED ON 13-DEC-2024 STATING THAT IT WAS A 24-HOUR INFUSION STARTING (B)(6) 2024 AT 1610. THE FILTER WAS LEAKING AND THE INFUSION WAS STOPPED AT 1454 ON (B)(6) 2024. THE HOLES, CUT, TEARS AND CRACKS NOTED TO THE FILTER WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20404247 ↗
• MalfunctionAug 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT WHEN THE PATIENT GOT UP TO GO TO THE WASHROOM, SHE NOTICED THE IV LINE WAS DISCONNECTED FROM THE FILTER LINE WHILE PACLITAXEL WAS INFUSING. THE MEDICATION SPILLED ON PATIENT'S HANDS, THE RN¿S HANDS, AND ON THE FLOOR. THE PUMP STOPPED AND WAS CLEANED USING A CHEMOTHERAPY SPILL KIT AND ACCORDING TO ALBERTA HEALTH SERVICE (AHS) POLICY. THE PATIENT CAME INTO DIRECT CONTACT WITH CYTOTOXIC DRUG AND INFUSION WAS DELAYED WHILE SPILL WAS CLEANED UP IMPACT OF THE INCIDENT. INVASIVE PROCEDURE IS NOT PROVIDED OR NOT APPLICABLE. ADDITIONALLY, IT WAS REPORTED THAT THE FILTER TUBING WAS COMPLETELY DISCONNECTED FROM THE IV TUBING WHEN THE STAFF NOTICED IT. IT IS UNKNOWN HOW LONG INTO INFUSION THE LEAK OCCURRED. NO REPORT OF A BLOOD LOSS OR BLEED BACK. THERE WAS PATIENT INVOLVEMENT AND NO APPARENT HARM-REACHED PATIENT/PERSON, INCONVENIENT.

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

  MAUDE report 17611134 ↗
• MalfunctionNov 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14¿ EXT SET W/0.2 MICRON FILTER, CLAVE ¿ CLEAR, CLAMP, ROTATING LUER WHERE A LEAK OF CHEMOTHERAPY WAS NOTED. IT WAS REPORTED THAT THE FINAL CHEMOTHERAPY, CISPLATIN, (OF DICEP CHEMOTHERAPY) HAD JUST BEEN STARTED AT 659 ML AN HOUR; THE PATIENT COMPLAINED OF FEELING SOMETHING WET ON HER LEGS AND ON HER GOWN. IT WAS ALSO REPORTED THAT THE INFUSION WAS STOPPED, AND A LEAK OF CHEMOTHERAPY COULD BE SEEN AT THE SIDE OF A 0.2 MICRON FILTER. A NEW FILTER WAS USED FOR THE REMAINDER OF THE INFUSION AND THE PATIENT¿S SKIN WAS WASHED AND HER CLOTHING WAS CHANGED. THERE WAS NO BLOOD LOSS OR BLEED BACK REPORTED. THERE WERE NO OBVIOUS DEFECTED NOTED ON THE TUBING SET. THERE WAS PATIENT INVOLVEMENT, AND A REPORT OF UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE HEALTHCARE PROVIDER OR THE PATIENT; BUT NO APPARENT HARM WAS REPORTED.

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

  MAUDE report 10859995 ↗
• MalfunctionSep 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH WAS RECEIVED THAT STATED ¿DURING CHEMOTHERAPY ADMINISTRATION, STAFF IDENTIFIED SMALL LEAKS WITH THE ICU MEDICAL 0.2-MICRON FILTERS ON THREE SEPARATE OCCASIONS. FILTERS PULLED OFF THE SHELF FOR REVIEW. NO STAFF EXPOSURE NOTED¿. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR PATIENT HARM REPORTED. THIS IS THE SECOND OF THREE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10537506 ↗
• MalfunctionSep 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH WAS RECEIVED THAT STATED ¿DURING CHEMOTHERAPY ADMINISTRATION, STAFF IDENTIFIED SMALL LEAKS WITH THE ICU MEDICAL 0.2-MICRON FILTERS ON THREE SEPARATE OCCASIONS. FILTERS PULLED OFF THE SHELF FOR REVIEW. NO STAFF EXPOSURE NOTED¿. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR PATIENT HARM REPORTED. THIS IS THE FIRST OF THREE EVENTS REPORTED.

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

  MAUDE report 10537485 ↗
• MalfunctionSep 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH WAS RECEIVED THAT STATED ¿DURING CHEMOTHERAPY ADMINISTRATION, STAFF IDENTIFIED SMALL LEAKS WITH THE ICU MEDICAL 0.2-MICRON FILTERS ON THREE SEPARATE OCCASIONS. FILTERS PULLED OFF THE SHELF FOR REVIEW. NO STAFF EXPOSURE NOTED¿. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR PATIENT HARM REPORTED. THIS IS THE THIRD OF THREE EVENTS REPORTED.

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

  MAUDE report 10537462 ↗

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-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-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-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-0246-2021 · Jul 6, 2020 · Terminated
  40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50
• Z-0184-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• Z-0243-2021 · Jul 6, 2020 · Terminated
  78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226.

…and 173 more.