ICU Medical B1016Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709000087), received between Jun 14, 2024 and Feb 21, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Disconnection; Disconnection

  THE EVENT INVOLVED A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE REPORTER STATED THAT THEY HAD TWO INCIDENTS WHERE THE TUBING HAS COME DISCONNECTED FROM THE FILTER WITH THE 1.2 MICRON FILTER SET AND THE TUBING THAT GOES TO THE PATIENT. IT OCCURRED RIGHT AT THE JUNCTION BETWEEN THE TUBING AND THE FILTER. THEY HAVE BEEN TOLD THAT THIS WAS THE SAME PLACE DISCONNECTIONS HAD OCCURRED IN OTHER INSTANCES. THE EVENT WAS NOTED DURING INFUSION. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440275 ↗
• MalfunctionAug 23, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT DURING INFUSION THE TOTAL PARENTERAL NUTRITION (TPN) FILTER BECAME DISCONNECTED FROM INTRAVENOUS (IV) TUBING SPONTANEOUSLY AND COULD NOT BE RECONNECTED. THE CUSTOMER CONFIRMED WITH REPORTER, FILTER SUDDENLY BECAME DISCONNECTED AND NOT SECONDARY TO PATIENT AGITATION. IT IS UNCLEAR HOW LONG THE TPN INFUSED INTO PATIENT'S BED. A NEW FILTER WAS SUPPLIED BY PHARMACY, AND THE BESIDE REGISTERED NURSE (RN) HAD NO TROUBLE CONNECTING FILTER AND RESUMING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND A DELAY OF THERAPY AS TEMPORARY DELAY INFUSION HAD TO BE PAUSED DUE TO LEAKING INTO THE BED. A NEW FILTER WAS DELIVERED, APPLIED AND INFUSION WAS RESTARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050614 ↗
• MalfunctionAug 22, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE EVENT INVOLVED A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE TOTAL PARENTERAL NUTRITION (TPN) FILTER BROKE DURING INFUSION. TPN RATE WAS 40 ML/HR. INFUSING VIA LEFT FEMORAL CENTRAL TRIPLE LUMEN. PATIENT WITH RESTRAINT ORDERS. THERE WAS NO HUMAN HARM, BUT A DELAY OF THERAPY AS INFUSION HAD TO BE PAUSED DUE TO LEAKING INTO THE BED, NEW FILTER DELIVERED, APPLIED AND INFUSION RESTARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033179 ↗
• MalfunctionAug 22, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER. THE 1.2 MICROFILTER REPORTEDLY 'BROKE OFF THE BLUE PART OF THE FILTER PIECE' AND THIS RESULTED IN LEAKING TOTAL PARENTERAL NUTRITION (TPN). THE TPN INFUSION WAS THEN STOPPED THE REST OF THE TUBING WAS EXAMINED AND IT LOOKED PATENT. THE MATERIALS DEPARTMENT WAS CALLED TO REPLACE THE FILTER. THE CUSTOMER WIPED THE ENDS DOWN WITH AN ALCOHOL PAD AND RESTARTED THE TPN INFUSION. PHARMACY SUPPLIED A NEW FILTER AND THE TPN WAS NOT WASTED. THE PATIENT WAS SLEEPING AT THE TIME OF THE EVENT AND NO KNOWN FACTORS CONTRIBUTED TO THE FILTER COMING APART. THERE WAS NO REPORT OF HUMAN HARM, HOWEVER THERE WAS AN UNSPECIFIED DELAY IN THERAPY DUE TO THE REQUIRED INFUSION PAUSE, AND THE NEED FOR A NEW FILTER FOR REPLACEMENT AND THEN RESTARTING THE PATIENT'S INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027471 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  AN EVENT INVOLVING A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER EXPERIENCED DISCONNECTION. THERE WAS A PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM. THE INITIAL REPORTER STATED THAT THE CUSTOMER WAS NOTIFIED BY BEDSIDE THAT THE TPN (TOTAL PARENTAL NUTRITION) FILTER BECAME SPONTANEOUSLY DISCONNECTED FROM THE TUBING. THE CUSTOMER ASKED TO STOP THE TPN, DISCONNECTED THE TUBING, AND INFORM THE COVERING SERVICE. THE CUSTOMER ALSO PROVIDED THE BEDSIDE RN WITH THE NUMBER FOR THE MAIN PHARMACY SO THAT A NEW TPN FILTER CAN BE SENT UP. THE CUSTOMER REQUESTED THAT THE BEDSIDE RN PLACE THE BROKEN TPN FILTER IN A BIOHAZARD BAG, IN CASE PHARMACY WISHES TO EXAMINE THE PRODUCT. SECOND EVENT FOR THE PATIENT, TPN RATE WAS 52 ML/HR. PER DOCUMENTATION INFUSING VIA LEFT FEMORAL CENTRAL TRIPLE LUMEN. UPON INSPECTION OF SAVED BROKEN FILTER TUBING THAT CONNECTS TO THE PATIENT (FEMALE END) DISCONNECTED FROM THE FILTER, PATIENT WITH RESTRAINT ORDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018184 ↗
• MalfunctionAug 9, 2024Material Separation; Material Separation

  AN EVENT INVOLVING A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER EXPERIENCED DISCONNECTION DURING PATIENT USE. THE CUSTOMER WENT IN TO SEE THE PATIENT AND THE PATIENT'S TUBING WAS DISCONNECTED FROM THE MICRON FILTER FOR HER TPN. THE FILTER WAS FULL OF BLOOD RETURN AND THE TUBE WAS NOT CONNECTED TO THE FILTER ANYMORE.¿ ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE PATIENT WAS A WHITE, FEMALE. THE REPORT WAS COMPLETED BY(B)(6), A HEALTH PROFESSIONAL FROM UMASS (B)(6) MEDICAL CENTER. IT WAS MENTIONED UNDER THE SECTION ADVERSE EVENT OR PRODUCT PROBLEM THAT IT WAS A PRODUCT PROBLEM. UPDATE: THE B1016 EXT SET WAS INITIALLY PLACED/USED ON (B)(6) 2024. THERE WAS NO ANY ISSUES NOTED OR OBSERVED DURING FLUSHING. ONE INFUSION INFUSING FOR 16 HOURS BEFORE THE ISSUE. THE AREA WHERE THE TUBING/FILTER SEPARATION WAS OBSERVED WAS UNKNOWN, REPORT STATES THE FILTER WAS NO LONGER CONNECTED TO THE TUBING. THERE WAS NO ANY ADDITIONAL CLINICAL OBSERVATIONS OR COMMENTS. SAMPLE PHOTO IS NOT AVAILABLE. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS/INVESTIGATION AS THE DEVICES WERE THROWN AWAY. THERE WERE NO SERIOUS INJURIES IN THE REPORTED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951647 ↗
• MalfunctionJul 17, 2024No Audible Alarm; Disconnection; No Audible Alarm; Disconnection

  THE EVENT INVOLVED A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER AND WAS REPORTED VIA A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# 2201630000-2024-8018). THE CUSTOMER REPORTED THAT THE PATIENT HAD CONTINUOUS TOTAL PARENTERAL NUTRITION (TPN) INFUSING, WITH A 1.2 FILTER AND IT WAS NOTED DURING HOURLY ROUNDS THAT THE FILTER HAD BECOME UNDONE FROM IV TUBING. TPN WAS ALL OVER FLOOR, IV PUMP WAS NOT BEEPING TO ALERT THE CUSTOMER; NEW TUBING AND FILTER WERE PLACED. THERE IS NO ADDITIONAL CLINICAL COMMENTS OR OBSERVATIONS REGARDING THESE EVENTS/PRODUCT ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762683 ↗
• MalfunctionJul 16, 2024Separation Problem; Separation Problem

  THE EVENT INVOLVED A 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER STATED WHEN THEY ENTERED THE PATIENT¿S ROOM AND THE TUBING THAT ATTACHES TO THE PATIENT FROM THE FILTER WAS DISCONNECTED. THEY ATTEMPTED TO RECONNECT AFTER WIPING WITH ETOH (ETHYL ALCOHOL) SWAP. THE TUBING WOULD NOT STAY IN PLACE, THE TUBING SLID RIGHT OFF THE FILTER. IT WOULD CONNECT BUT NOT STAY IN PLACE THE WHOLE PRODUCT WAS REMOVED AND REPLACED WITH ANOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756048 ↗
• MalfunctionJun 14, 2024Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED SEVERAL DEVICES BEING BROKEN CREATING INTERRUPTION IN PATIENT CARE AND NEEDED THERAPY. MOSTLY EVENTS WERE REPORTED FROM PEDIATRIC INTENSIVE CARE UNIT (PICU). IT WAS STATED THAT THE TUBING IS SEPARATING WHERE IT IS ATTACHED TO THE BLUE FILTER. THE PIECE IS A PERMANENT ATTACHMENT TO THE FILTER ITSELF. THE FILTER WAS CONNECTED TO THE INTRAVENOUS (IV) TUBING AND ATTACHED TO THE PATIENT. THE PATIENT INVOLVED WAS A NEUTROPENIC PATIENT AND THE EVENT RESULTED IN A LARGE AMOUNT OF BLOOD IN THE BED, HOWEVER, THE VOLUME WASN'T LARGE ENOUGH TO REQUIRE TRANSFUSION. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19536553 ↗

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-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV 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-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-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-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-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)1
• Z-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per
• Z-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906
• 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-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-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-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948

…and 173 more.