ICU Medical B55013Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709010116), received between Mar 11, 2021 and Apr 6, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 12" EXT SET, 3 GANG 1O2® MANIFOLD W/BASEPLATE, ROTATING LUER WHERE THE BRIDGE FOR SEDATION/PARALYTIC WAS FOUND TO BE LEAKING. SUBTLE LEAKS WERE REPORTED TO BE DIFFICULT TO SEE HOWEVER, IT WAS SUSPECTED THAT THE LEAKAGE WAS COMING FROM WHERE THE PLASTIC MEETS THE PORT. THE LEAK OCCURRED WITHIN 12 HOURS OF USING AS A NEW ADMISSION. THE PROBLEM WAS NOTICED WHEN THE PATIENT STARTED MOVING HIS HEAD. IT WAS REPORTED THAT THE PATIENT WAS ON PROPOFOL AT 4MG/KG/HR, DILAUDID AT 3MG/HR AND CISATRACURIUM AT 10MG/HR. THE REPORTER MENTIONED THAT THE PATIENT TYPICALLY DE-SATURATES DRAMATICALLY WHEN PARALYTIC IS OFF, BUT FORTUNATELY IT DID NOT HAPPEN THIS TIME. AFTER THE PATIENT BECAME AGITATED, THE BRIDGE WAS CHANGED OUT AND BOLUSES WERE GIVEN FOR QUICK RE-SEDATION. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625056 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT WAS NOTED ON THE NIGHTSHIFT AND INVOLVED A 12¿ EXTENSION SET, 3 GANG 1O2® MANIFOLD W/BASEPLATE, ROTATING LUER WHERE A SMALL CRACK WAS NOTED IN THE MANIFOLD CAUSING LIFESAVING MEDICATION TO SLOWLY LEAK, REPORTING THE LEAKAGE WAS SUBTLE SO ACCUMULATION WAS NOT NOTED. LEAKING WAS NOTED AT THE BRIDGE AND A WET SPOT ON THE LINEN WAS NOTED WHERE THE BRIDGE SAT. VASOPRESSORS (EPINEPHRINE, NOREPINEPHRINE), NARCOTICS (FENTANYL, DILAUDID), IV SEDATION (PROPOFOL) OR MAINTENANCE IV¿S (D5/.9 OR NS) WERE INFUSING THROUGH THE 3 PORTS. THE SET UP WAS CONTINUOUS IV TUBING WITH A MINIBORE EXTENSION SET, CONNECTED TO THE BRIDGE OF THE DEVICE. THE EVENT WAS DISCOVERED WHEN THE PATIENT BECAME MORE CONSCIOUS, FIGHTING THE VENTILATOR OR A BLOOD PRESSURE DROP WAS NOTED DUE TO LEAKAGE OF MEDICATIONS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE REQUIRING AN INTERVENTION OF A CONTINUOUS INFUSION WITH THE PROVIDED DRUGS USED DURING THE EVENT TO INCREASE THE PATIENT¿S BLOOD PRESSURE AND IMPROVE PATIENT CONDITION TO AVOID EXTUBATION AND MAKE THE AGITATED PATIENT MORE SETTLED AS THE PATIENT BECAME RESTLESS AND TRIED TO PULL OUT THEIR BREATHING TUBE. IT WAS REPORTED THAT THE PATIENT WAS STABLE BEFO

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467440 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 12¿ EXTENSION SET, 3 GANG 1O2® MANIFOLD W/BASEPLATE, ROTATING LUER WHERE A SMALL CRACK WAS NOTED IN THE MANIFOLD CAUSING LIFESAVING MEDICATION TO SLOWLY LEAK, REPORTING THE LEAKAGE WAS SUBTLE SO ACCUMULATION WAS NOT NOTED. LEAKING WAS NOTED AT THE BRIDGE AND A WET SPOT ON THE LINEN WAS NOTED WHERE THE BRIDGE SAT. VASOPRESSORS (EPINEPHRINE, NOREPINEPHRINE), NARCOTICS (FENTANYL, DILAUDID), IV SEDATION (PROPOFOL) OR MAINTENANCE IV¿S (D5/.9 OR NS) WERE INFUSING THROUGH THE 3 PORTS. THE SET UP WAS CONTINUOUS IV TUBING WITH A MINIBORE EXTENSION SET, CONNECTED TO THE BRIDGE OF THE DEVICE, WHICH WAS IN USE FOR A MAXIMUM OF 3 DAYS. THE EVENT WAS DISCOVERED WHEN THE PATIENT BECAME MORE CONSCIOUS, FIGHTING THE VENTILATOR OR A BLOOD PRESSURE DROP WAS NOTED DUE TO LEAKAGE OF MEDICATIONS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE REQUIRING AN INTERVENTION OF A CONTINUOUS INFUSION WITH THE PROVIDED DRUGS USED DURING THE EVENT TO INCREASE THE PATIENT¿S BLOOD PRESSURE AND IMPROVE PATIENT CONDITION TO AVOID EXTUBATION AND MAKE THE AGITATED PATIENT MORE SETTLED AS THE PATIENT BECAME RESTLESS AND TRIED TO PULL OUT THEIR BREATHING TUBE. IT WAS REPORTED THAT THE PATIENT WAS S

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467412 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 12¿ EXTENSION SET, 3 GANG 1O2® MANIFOLD W/BASEPLATE, ROTATING LUER WHERE A SMALL CRACK WAS NOTED IN THE MANIFOLD CAUSING LIFESAVING MEDICATION TO SLOWLY LEAK, REPORTING THE LEAKAGE WAS SUBTLE SO ACCUMULATION WAS NOT NOTED. LEAKING WAS NOTED AT THE BRIDGE AND A WET SPOT ON THE LINEN WAS NOTED WHERE THE BRIDGE SAT. VASOPRESSORS (EPINEPHRINE, NOREPINEPHRINE), NARCOTICS (FENTANYL, DILAUDID), IV SEDATION (PROPOFOL) OR MAINTENANCE IV¿S (D5/.9 OR NS) WERE INFUSING THROUGH THE 3 PORTS. THE SET UP WAS CONTINUOUS IV TUBING WITH A MINIBORE EXTENSION SET, CONNECTED TO THE BRIDGE OF THE DEVICE, WHICH WAS IN USE FOR A MAXIMUM OF 3 DAYS. THE EVENT WAS DISCOVERED WHEN THE PATIENT BECAME MORE CONSCIOUS, FIGHTING THE VENTILATOR OR A BLOOD PRESSURE DROP WAS NOTED DUE TO LEAKAGE OF MEDICATIONS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE REQUIRING AN INTERVENTION OF A CONTINUOUS INFUSION WITH THE PROVIDED DRUGS USED DURING THE EVENT TO INCREASE THE PATIENT¿S BLOOD PRESSURE AND IMPROVE PATIENT CONDITION TO AVOID EXTUBATION AND MAKE THE AGITATED PATIENT MORE SETTLED AS THE PATIENT BECAME RESTLESS AND TRIED TO PULL OUT THEIR BREATHING TUBE. IT WAS REPORTED THAT THE PATIENT WAS S

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467385 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 12¿ EXTENSION SET, 3 GANG 1O2® MANIFOLD W/BASEPLATE, ROTATING LUER WHERE A SMALL CRACK WAS NOTED IN THE MANIFOLD CAUSING LIFESAVING MEDICATION TO SLOWLY LEAK, REPORTING THE LEAKAGE WAS SUBTLE SO ACCUMULATION WAS NOT NOTED. LEAKING WAS NOTED AT THE BRIDGE AND A WET SPOT ON THE LINEN WAS NOTED WHERE THE BRIDGE SAT. VASOPRESSORS (EPINEPHRINE, NOREPINEPHRINE), NARCOTICS (FENTANYL, DILAUDID), IV SEDATION (PROPOFOL) OR MAINTENANCE IV¿S (D5/.9 OR NS) WERE INFUSING THROUGH THE 3 PORTS. THE SET UP WAS CONTINUOUS IV TUBING WITH A MINIBORE EXTENSION SET, CONNECTED TO THE BRIDGE OF THE DEVICE, WHICH WAS IN USE FOR A MAXIMUM OF 4 DAYS. THE EVENT WAS DISCOVERED WHEN THE PATIENT BECAME MORE CONSCIOUS, FIGHTING THE VENTILATOR OR A BLOOD PRESSURE DROP WAS NOTED DUE TO LEAKAGE OF MEDICATIONS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE REQUIRING AN INTERVENTION OF A CONTINUOUS INFUSION WITH THE PROVIDED DRUGS USED DURING THE EVENT TO INCREASE THE PATIENT¿S BLOOD PRESSURE AND IMPROVE PATIENT CONDITION TO AVOID EXTUBATION AND MAKE THE AGITATED PATIENT MORE SETTLED AS THE PATIENT BECAME RESTLESS AND TRIED TO PULL OUT THEIR BREATHING TUBE. IT WAS REPORTED THAT THE PATIENT WAS S

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467384 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  INFORMATION WAS RECEIVED STATING THAT THE NURSES AT THE FACILITY ONLY MANUALLY TIGHTEN THE DEVICE AND USE CHLORHEXIDINE GLUCONATE (CHG) WIPES TO WIPE THE DEVICE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467372 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 12¿ EXTENSION SET, 3 GANG 1O2® MANIFOLD W/BASEPLATE, ROTATING LUER WHERE A SMALL CRACK WAS NOTED IN THE MANIFOLD CAUSING LIFESAVING MEDICATION TO SLOWLY LEAK, REPORTING THE LEAKAGE WAS SUBTLE SO ACCUMULATION WAS NOT NOTED. LEAKING WAS NOTED AT THE BRIDGE AND A WET SPOT ON THE LINEN WAS NOTED WHERE THE BRIDGE SAT. VASOPRESSORS (EPINEPHRINE, NOREPINEPHRINE), NARCOTICS (FENTANYL, DILAUDID), IV SEDATION (PROPOFOL) OR MAINTENANCE IV¿S (D5/.9 OR NS) WERE INFUSING THROUGH THE 3 PORTS. THE SET UP WAS CONTINUOUS IV TUBING WITH A MINIBORE EXTENSION SET, CONNECTED TO THE BRIDGE OF THE DEVICE, WHICH WAS IN USE ABOUT 6 HOURS. THE EVENT WAS DISCOVERED WHEN THE PATIENT BECAME MORE CONSCIOUS, FIGHTING THE VENTILATOR OR A BLOOD PRESSURE DROP WAS NOTED DUE TO LEAKAGE OF MEDICATIONS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE REQUIRING AN INTERVENTION OF A CONTINUOUS INFUSION WITH THE PROVIDED DRUGS USED DURING THE EVENT TO INCREASE THE PATIENT¿S BLOOD PRESSURE AND IMPROVE PATIENT CONDITION TO AVOID EXTUBATION AND MAKE THE AGITATED PATIENT MORE SETTLED AS THE PATIENT BECAME RESTLESS AND TRIED TO PULL OUT THEIR BREATHING TUBE. IT WAS REPORTED THAT THE PATIENT WAS STABLE BEFO

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467359 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 12¿ EXTENSION SET, 3 GANG 1O2® MANIFOLD W/BASEPLATE, ROTATING LUER WHERE A SMALL CRACK WAS NOTED IN THE MANIFOLD CAUSING LIFESAVING MEDICATION TO SLOWLY LEAK, REPORTING THE LEAKAGE WAS SUBTLE SO ACCUMULATION WAS NOT NOTED. LEAKING WAS NOTED AT THE BRIDGE AND A WET SPOT ON THE LINEN WAS NOTED WHERE THE BRIDGE SAT. VASOPRESSORS (EPINEPHRINE, NOREPINEPHRINE), NARCOTICS (FENTANYL, DILAUDID), IV SEDATION (PROPOFOL) OR MAINTENANCE IV¿S (D5/.9 OR NS) WERE INFUSING THROUGH THE 3 PORTS. THE SET UP WAS CONTINUOUS IV TUBING WITH A MINIBORE EXTENSION SET, CONNECTED TO THE BRIDGE OF THE DEVICE, WHICH WAS IN USE WITHIN HOURS. THE EVENT WAS DISCOVERED WHEN THE PATIENT BECAME MORE CONSCIOUS, FIGHTING THE VENTILATOR OR A BLOOD PRESSURE DROP WAS NOTED DUE TO LEAKAGE OF MEDICATIONS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE REQUIRING AN INTERVENTION OF A CONTINUOUS INFUSION WITH THE PROVIDED DRUGS USED DURING THE EVENT TO INCREASE THE PATIENT¿S BLOOD PRESSURE AND IMPROVE PATIENT CONDITION TO AVOID EXTUBATION AND MAKE THE AGITATED PATIENT MORE SETTLED AS THE PATIENT BECAME RESTLESS AND TRIED TO PULL OUT THEIR BREATHING TUBE. IT WAS REPORTED THAT THE PATIENT WAS STABLE BEFOR

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467347 ↗
• InjuryMar 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  INFORMATION WAS RECEIVED STATING THAT THE NURSES AT THE FACILITY ONLY MANUALLY TIGHTEN THE DEVICE AND USE CHLORHEXIDINE GLUCONATE (CHG) WIPES TO WIPE THE DEVICE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11467335 ↗

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-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-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-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906
• Z-0187-2021 · Jul 6, 2020 · Terminated
  7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877090510
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• 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-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.