ICU Medical B1478Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709001916), received between Nov 24, 2024 and Dec 8, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE (NOVEMBER 1ST USED AS PLACEHOLDER) AND INVOLVED A 7" (18 CM) SMALLBORE EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUE. THE CUSTOMER REPORTED THAT THE FILTER WAS LEAKING. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR NOT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739247 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO 7" (18CM) SMALLBORE EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE DURING USE. THE REPORT STATED THAT CALLED TO BEDSIDE DUE TO BLOOD BACKING UP INTO PICC LINE. ON FURTHER ASSESSMENT, IT WAS NOTED THAT THE TPN/IL INFUSION WAS LEAKING FROM SOMEWHERE. ABLE TO FLUSH BLOOD THROUGH LINE AND CLEAR LINE WITH TPN AND LIPIDS CLAMPED. FURTHER INSPECTION SHOWED THAT THE LINE WAS LEAKING BETWEEN LIPIDS AND THE TRIFUSE. MEDICAL TEAM OPTED JUST TO REPLACE LIPID LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634687 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) OF 2024 INVOLVING 7" SMALLBORE EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE A REPORT STATED THAT AN RN NOTED LARGE AIR BUBBLE PAST 1.2 MICRON (LIPID) FILTER. REQUIRED DETACHING LIPIDS LINE FROM PATIENT IN ORDER TO GET AIR OUT. THE DECISION WAS MADE TO REMOVE CURRENT FILTER AND PLACE NEW FILTER. AIR DID NOT REACH PATIENT. THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS. IT WAS UNKNOWN ON HOW LONG INTO THE INFUSION WAS THE AIR BUBBLE NOTED. THE AIR BUBBLE WAS LARGE. IT WAS UNKNOWN WHAT WAS THE LENGTH OF THE TUBING THE AIR BUBBLES WERE IN. IT WAS UNKNOWN HOW THE TUBING WAS SET-UP. IT WAS UNKNOWN IF THE DRIP CHAMBER WAS FILLED BEFORE THE BUBBLES WERE NOTED. IT WAS UNKNOWN IF A PUMP WAS USED DURING THE INFUSION. IT WAS UNKNOWN IF IT ALARMS FOR AIR IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852165 ↗
• MalfunctionNov 24, 2024No Flow; No Flow

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 7" SMALLBORE EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER THAT EXPERIENCED NO FLOW DURING USE. THE REPORTER STATED THAT THE B1478 WAS CLOTTING BETWEEN 12-15 HOURS. THE ACCOUNT COULD NO LONGER FILTER LIPIDS DUE TO THE INCREASED RISK OF CLABSI CAUSED BY ADDITIONAL DISCONNECTIONS OF THE FILTER DURING PATIENT USE. THEN, WHEN AN ICU MEDICAL CLINICAL SALES CONSULTANT VISITED THE SITE ON (B)(6) 2024, STATED THAT LIPIDS WERE NOT BEING FILTERED CURRENTLY AS THEY COMPLAIN THAT THE B1478 DOES NOT HAVE THE 24-HOUR LONGEVITY. IT WAS ALSO STATED THAT IT CLOTS OFF AT THE 12¿15-HOUR MARK. THE EVENT DATE IS ONGOING APPROXIMATELY FOR ONE CALENDAR YEAR. STATUS WAS DURING PATIENT USE. SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN IN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767743 ↗

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-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-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-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-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
• Z-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090
• Z-0199-2021 · Jul 6, 2020 · Terminated
  9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)455847
• Z-0253-2021 · Jul 6, 2020 · Terminated
  60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular
• Z-0229-2021 · Jul 6, 2020 · Terminated
  78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The I
• 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;

…and 173 more.