ICU Medical B1339Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709001190), received between Mar 31, 2021 and Dec 14, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2025Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED AN 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER AND IT WAS REPORTED THAT PATIENT RECEIVING VENOFER INFUSION USING PORTLESS LINE REQUIRING HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT) FILTER. THREE HHT FILTERS WERE ATTEMPTED TO BE USED WITH THIS PATIENT. AIR BUBBLES CONTINUED TO KEEP APPEARING FROM HHT FILTER ATTACHMENT. HHT FILTER WITH A DIFFERENT LOT WAS USED AND WORKS WELL WITH NO AIR BUBBLES. THERE WERE NO PATIENT HARM AND MINIMAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799907 ↗
• MalfunctionJul 23, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS STATED IN THE REPORT THAT THE CLIENT WAS RECEIVING CHEMOTHERAPY AND SHE NOTICED THAT SOMETHING WAS WET ON THE ARMREST. THEY STOPPED INFUSIONS TO FIND OUT WHERE THE LEAK WAS AND FOUND THAT THE RIGID PLASTIC TUBE HAD COME OUT OF THE CENTER OF THE FILTER THAT WAS ON THE PACLITAXEL LINE. THE MEDICATION ON THE AFFECTED LINE HAD ALREADY BEEN INFUSED, FLUSHED AND THE LINE CLAMPED ABOUT 45 MINUTES PRIOR. AT THE TIME OF THE INCIDENT, IT HAD BEEN RUNNING NORMAL SALINE ONLY, AT (B)(4). THERE COLLEAGUE ASSISTED WITH THE CLEANUP OF THE SPILLED NORMAL SALINE AND DESK NURSE WAS MADE AWARE. THE AFFECTED LINE WAS REMOVED. THE OTHER CHEMOTHERAPY LINE WAS NOT AFFECTED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND UNKNOWN DELAY IN INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813263 ↗
• MalfunctionJun 23, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS STATED IN THE REPORT THAT THE CLIENT WAS RECEIVING CHEMOTHERAPY AND SHE NOTICED THAT SOMETHING WAS WET ON THE ARMREST. THEY STOPPED INFUSIONS TO FIND OUT WHERE THE LEAK WAS AND FOUND THAT THE RIGID PLASTIC TUBE HAD COME OUT OF THE CENTER OF THE FILTER THAT WAS ON THE PACLITAXEL LINE. THE MEDICATION ON THE AFFECTED LINE HAD ALREADY BEEN INFUSED, FLUSHED AND THE LINE CLAMPED ABOUT 45 MINUTES PRIOR. AT THE TIME OF THE INCIDENT, IT HAD BEEN RUNNING NORMAL SALINE ONLY, AT 30 MLS/HR. THERE COLLEAGUE ASSISTED WITH THE CLEANUP OF THE SPILLED NORMAL SALINE AND DESK NURSE WAS MADE AWARE. THE AFFECTED LINE WAS REMOVED. THE OTHER CHEMOTHERAPY LINE WAS NOT AFFECTED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND UNKNOWN DELAY IN INFUSION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591738 ↗
• MalfunctionMar 31, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED AN 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE 0.2 MICRON FILTER DETACHED AT THE HUB, MAKING AN OPEN SYSTEM. DURING AN INFUSION OF CARBOPLATIN, THE PATIENT CALLED THE NURSE WHERE IT WAS FOUND THAT BLOOD AND FLUID WAS ON THE BLANKET, CHAIR, AND THE PATIENT¿S CLOTHING. BLOOD WAS REPORTED TO BE FLOWING FROM A LINE THAT WAS NOT BEING USED, THAT HAD PREVIOUSLY BEEN INFUSING PACLITAXEL. THE FILTER FROM THE PACLITAXEL LINE WAS FOUND TO BE DISCONNECTED FROM FILTER AND THE FILTER TUBING WAS DISCONNECTED FROM HUB. THE LINE WAS CLAMPED WITH KELLY CLAMP. THE CARBOPLATIN AND MAIN LINE WERE PAUSED. APPROXIMATELY 100ML WAS REMAINING IN CARBOPLATIN BAG. THE SPILL WAS CLEANED UP PER PROTOCOL USING A SPILL KIT. THE TUBING WAS NOT REPLACED, THE THERAPY WAS NOT RESUMED. A VERBAL ORDER WAS GIVEN BY THE NURSE PRACTITIONER TO NOT GIVE THE REMAINING CARBOPLATIN. THERE WAS NO HOLE, CUT, TEARS OR DEFECT NOTED. THERE WAS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS UNPROTECTED CHEMO EXPOSURE TO THE PATIENT AND/OR THE HEALTHCARE PROVIDER REPORTED, THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Chemical Exposure; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599960 ↗

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-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-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-0255-2021 · Jul 6, 2020 · Terminated
  148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intrav
• Z-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(
• Z-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• 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-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case
• 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
• 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

…and 173 more.