ICU Medical B1729Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709073951), received between Jul 23, 2020 and May 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5.5" EXT SET W/0.2 MICRON FILTER, LUER LOCK WHERE IT WAS REPORTED THAT DURING THE FIRST TITRATION STEP, PATIENT STATED HE NOTICED HIS MICRON FILTER WAS LEAKING AND PILLOWCASE HE WAS RESTING HIS ARM ON WAS WET. INFUSION WAS IMMEDIATELY STOPPED. THERE WAS PATIENT INVOLVEMENT AND NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390695 ↗
• MalfunctionOct 16, 2020Obstruction of Flow

  FILTER ATTACHMENT TO IV TUBING OCCLUDED, FLUID WOULD NOT RUN DURING SIMPONI ARIA INFUSION. CHANGED PUMPS, CHECKED ALL PORTS AND EQUIPMENT. WHEN REQUIRED FILTER ATTACHMENT WAS REMOVED THE OCCLUSION WAS GONE. FILTER ATTACHMENT WAS REPLACED AND INFUSION WAS COMPLETED WITHOUT FURTHER COMPLICATION. FILTER ATTACHMENT PART REFERENCE NUMBER B1729, LOT 4799732, EXPIRATION 04/01/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10689709 ↗
• MalfunctionJul 23, 2020Positioning Problem

  THERE HAS BEEN THREE SEPARATE EVENTS IN THE NICU INVOLVING THE USE OF THE ICU MEDICAL B1729 LUER LOCK EXTENSION SET WITH 0.2 MICRON FILTER. THE FIRST EVENT ((B)(4)) NOTED THE MALFUNCTIONING OF A B1729 IV EXT SET CONNECTED TO AN UMBILICAL VENOUS CATHETER (UVC). WHEN THE MICRON FILTER WAS PLACED AT THE SAME LEVEL AS THE NEWBORN PATIENT, THE UVC BLED BACK INTO THE IV LINE AND TUBING. THE MICRON FILTER WORKED AS EXPECTED WHEN HELD IN THE "HOUSE UP" POSITION. THE IV FLOW RATE DURING THIS EVENT WAS 17.5 ML/HR. THE ISSUE WITH THE B1729 EXT SET STARTED WHEN THE FILTER HAD TO BE ADDED TO THE NO-PORT IV TUBING. THE 0.2 FILTER IS SHORTER THAN THE FILTERS USED IN THE PAST WHICH ARE 14 CM IN TOTAL LENGTH. THE SECOND EVENT ((B)(4)) INVOLVED BLOOD BACKING UP IN THE UVC LINE USING THE B1729 MICRON FILTER CONNECTED TO A BD ALARIS IV INFUSION SET. THE BD IV PUMP WAS USED TO INFUSE FLUIDS AT A RATE OF 7.3 DURING A TOTAL PARENTERAL NUTRITION (TPN) PROCEDURE. RN NOTED THE PRESENCE OF BLOOD IN THE LINE AND CALLED THE PHYSICIAN. HEALTH CARE PROVIDERS NOTED THAT FLUID STARTED TO FLOW NORMALLY ON THE IV SET WHEN THE FILTER WAS HELD IN A VERTICAL POSITION (UP HIGHER IN THE AIR). BLOOD STARTED BACKING UP IN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312078 ↗

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-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-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-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-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• 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-0251-2021 · Jul 6, 2020 · Terminated
  60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Ad
• 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-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-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-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.