ICU Medical B2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709002937), received between Dec 27, 2024 and Aug 5, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE COMPLAINT INVOLVED A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK DEVICE. A SMALL COLLECTION OF FLUID WAS REPORTED ON THE SYRINGE PUMP BELOW THE CONNECTION FROM THE SYRINGE TO THE TUBING. THE PUMP WAS NOTED TO FEEL WET ON THE BOTTOM. ALSO, THEY NOTED A SMALL COLLECTION OF FLUID ON THE FLOOR BELOW THE IV POLE. THE STAFF ASSUMED IT WAS CAUSED FROM A LOOSE CONNECTION; AND THE TUBING WAS CHANGED WITH A NEW SYRINGE. THE STAFF TESTED THE CONNECTION BY FLUSHING THE PORT WITH SALINE AND NOTED TO BE A CRACK/LEAK NOTED ON THE IV TUBING BELOW THE CLAVE. THERE WAS UNEXPECTED OR PROLONGED CARE. THE REPORT STATED THAT THE STAFF WENT INTO ROOM TO CHANGE THE EMPTY DEXMEDETOMIDINE SYRINGE. THE TUBING WAS ATTACHED TO A MICROCLAVE AND 10 ML PREFILLED SALINE SYRINGE THESE ITEMS WILL BE RETURNED FOR EVALUATION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719522 ↗
• MalfunctionJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK THAT WAS REPORTEDLY LEAKING DURING USE ON A PATIENT, ADMINISTERING BIVALRUDIN. THERE WAS NO ADVERSE EVENT NOR ANY DELAY IN THERAPY THAT WOULD LEAD TO PATIENT HARM IF NOT CAUGHT BY STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502864 ↗
• MalfunctionJun 26, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK WAS FOUND TO HAVE EXPERIENCED A LEAK DURING PATIENT USE. IT WAS REPORTED THAT THAT FLUID WAS DRIPPING TO THE FLOOR BY THE INTRAVENOUS (IV) POLE. UPON INVESTIGATION, MORPHINE WAS FOUND TO BE LEAKING FROM THE TUBING WHERE THE SMARTSITE CONNECTS TO THE TUBING. ADDITIONALLY, THERE WAS A CRACK IN THE TUBING. IT WAS ALSO MENTIONED THAT THE PATIENT HAD ABNORMAL VITALS (TEMPERATURE/HR, RR), WORK OF BREATHING, AND AGITATION EMESIS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341202 ↗
• MalfunctionMay 16, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK WHERE IT WAS REPORTED THAT THERE IS A CRACK IN THE TUBING CAUSING IT TO LEAK WHEN ADMINISTERING MORPHINE AT THE SMARTSITE CONNECTION. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036181 ↗
• MalfunctionMay 16, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK WHERE IT WAS REPORTED THAT THERE IS A CRACK IN THE TUBING CAUSING IT TO LEAK WHEN ADMINISTERING CEFEPIME AT THE SMARTSITE CONNECTION. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035946 ↗
• MalfunctionMay 8, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK THAT EXPERIENCED LEAKAGE DURING PATIENT USE. IT WAS REPORTED THAT THERE IS A CRACK IN THE TUBING CAUSING IT TO LEAK WHEN ADMINISTERING MEDICATION AT THE SMARTSITE CONNECTION. THE MEDICATION THAT WAS LEAKING AT THE TIME OF THE EVENT WAS SEDATION DRUG. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989265 ↗
• MalfunctionDec 27, 2024No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK THAT EXPERIENCED NO FLOW. IT WAS REPORTED THAT THE "PUMP ERROR CODE INDICATING 'HIGH PRESSURE' IN THE SYRINGE PUMP, RESISTANCE. IMPOSSIBLE TO ADMINISTER MANNITOL WITH THE SYRINGE PUMP, LOSS OF TIME AND INCREASED WORKLOAD FOR THE NURSE. DELAY IN ADMINISTERING MEDICATION TO THE USER. PRODUCTS THAT CAUSED ERROR CODES HAVE BEEN DISCARDED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031128 ↗

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-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-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-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-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-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-0245-2021 · Jul 6, 2020 · Terminated
  126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intrav
• Z-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• Z-0195-2021 · Jul 6, 2020 · Terminated
  109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotati
• 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

…and 173 more.