ICU Medical B9438Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709013889), received between Apr 17, 2025 and Nov 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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.

• MalfunctionNov 17, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED AN 8" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER AND IT WAS REPORTED THAT THE CATHETER OR TUBING CRACKED/DAMAGED/SEVERED. IT WAS FOUND WITH INTRAVENOUS (IV) TUBING SEVERED 1-2INCHES ABOVE T-CONNECTOR. THE LINE WAS OPEN AND BLOOD WAS LEAKING. THE LINE WAS REMOVED IMMEDIATELY AND APPROPRIATE CARE COMPLETED AND THE CATHETER REMAINED INTACT. THE MEDICATION USED WERE FLUMAZENIL, ONDANSETRON, DEXMEDETOMIDINE, DEXAMETHASONE, KETOROLAC, PROPOFOL, AND REMIFENTANIL. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM/ INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23566303 ↗
• MalfunctionAug 26, 2025Separation Problem; Separation Problem

  EVENT OCCURRED REGARDING AN 8" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER WHERE THEY STATED THAT "TUBING WAS TWISTED AND WHEN ASSESSING IV, THE T CONNECTOR HAD FALLEN APART NEAR THE BLUE HUB. IV REMAINED IN PLACE AS WELL AS BLUE T CONNECTOR PIECE BUT MAIN LINE PULLED OUT. IV WAS ABLE TO SAVE BUT NEEDED TO CHANGE THE T CONNECTOR." THIS EVENT OCCURRED DURING PATIENT USE. THEY ALSO STATED THAT "THE DEVICE WAS USED FOR 2DAYS AND THE MEDICATIONS USED WERE D5NS RUNNING VIA IV AND CEFAZOLIN IV GIVEN AS AN ANTIBIOTIC. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE." THERE WAS PATIENT INVOLVEMENT, UNKNOWN ADVERSE EVENT AND NO DELAY IN THERAPY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896939 ↗
• MalfunctionApr 17, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 8" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER WHERE IT WAS REPORTED A PATIENT WAS HAVING LARYNGOSPASM. IV INSERTED WITH NO ISSUE. DRUGS WERE GIVEN DIRECTLY IN THE CATHETER TO TREAT THE LARYNGOSPASM BEFORE THE IV LINE WAS CONNECTED. WHEN THE IV LINE WAS CONNECTED, IT WAS DIFFICULT TO CONNECT TO T-CONNECTOR TO CATHETER. WHEN CATHETER WAS CONNECTED, THE LINE WAS LEAKING. ISSUE WAS RESOLVED ONCE THE T-CONNECTOR WAS CHANGED. WHEN DEFECTIVE T-CONNECTOR WAS INSPECTED, A LARGE CRACK WAS FOUND IN THE SLIP TIP PORTION OF THE CONNECTOR ALONG WITH AN EXTRA PIECE OF PLASTIC BENT INSIDE THE CONNECTOR. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858046 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN 8" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE PATIENT CAME OUT FROM OPERATING ROOM AT 14:22 AND THE PATIENT HAD PIV FLUID INFUSING WELL. WHEN ACCESSING BLUE PORT FROM EXTENSION SET, THE PORT CRACKED AND FELL OFF. BLOOD FROM PATIENT BACK FLOWED VIA DEFECTIVE PORT AND THERE WAS APPROXIMATELY 5ML BLOOD LOSS. THE PATIENT INVOLVED WAS AUTISTIC AND WAS DISTRESSED MORE BY EVENT. THE EXTENSION SET WAS REPLACED, AND PAIN MEDICATION WAS ABLE TO BE ADMINISTERED VIA NEW EXTENSION SET.

  Patient problems: Anxiety; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21857661 ↗

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-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-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-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0191-2021 · Jul 6, 2020 · Terminated
  5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101
• Z-0208-2021 · Jul 6, 2020 · Terminated
  12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(3
• Z-0205-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)5
• Z-0260-2021 · Jul 6, 2020 · Terminated
  124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034
• 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-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:(

…and 173 more.