ICU Medical SC9045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709040625), received between Nov 1, 2023 and Oct 7, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Air/Gas in Device; Air/Gas in Device

  THE COMPLAINT/EVENT INVOLVED A 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT, BECAUSE THE FILTER COULD NOT REMOVE AIR FROM THE IV SET, THE STAFF NURSES SPENT ADDITIONAL TIME TO DEAL WITH THE AIR LEFT IN THE INFUSION LINE. THE INCIDENT OCCURRED DURING A PATIENT INFUSION ON THE EVENING SHIFT. THERE WAS NO REPORT OF ANY HUMAN HARM AS A RESULT OF THE COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20390001 ↗
• MalfunctionOct 7, 2024No Flow; No Flow

  THE COMPLAINT/EVENT OCCURRED DURING THE EVENING SHIFT AND INVOLVED A 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THE INFUSION LINE WITH THIS FILTER CAUSED BLOOD RETURN, AND ALSO CAUSED THE PERIPHERALLY INSERTED CENTRAL CATHETERS (PICCS) TO BE BLOCKED AND UNUSABLE. THIS ISSUE REQUIRED RE-INSERTION OF AN I.V. CATHETER TO PROVIDE FLUIDS AND NUTRITION TO THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389443 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER EXPERIENCED A BREAK. THE REPORTER STATED THE TUBE/SET BROKE WHILE BEING USED WITH A PATIENT. THE SET-UP INCLUDED A 250ML BAG OF NORMAL SALINE SPIKED WITH A METER TUBING, WHICH WAS THEN ATTACHED TO THE FILTER. THE MEDICATION INVOLVED WAS REMICADE. IT WAS FURTHER REPORTED THAT THE TUBING SETUP WAS NOT REPLACED AND THERAPY WAS NOT RESUMED. THE PATIENT WAS INFORMED OF HOW MUCH MEDICATION WAS LEFT IN THE INFUSION BAG. THE PATIENT ONLY HAD WHAT WAS LEFT IN THE PRIMING CHAMBER. THE PATIENT WAS ASKED IF SHE WISHED TO CONTINUE WITH WHAT WAS LEFT, HOWEVER, THE PATIENT DENIED IT. NO MEDICATION INTERVENTION WAS REQUIRED, THE PATIENT WAS DISCONNECTED AND WENT HOME. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM WAS REPORTED, THE PATIENT JUST GOT UPSET FOR GETTING WET ON HER ARM AND LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107889 ↗
• MalfunctionNov 3, 2023Break; Break

  THE INCIDENT INVOLVED A 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THEY HAD A TUBE/SET THAT BROKE WHILE USING WITH A PATIENT. THE SET-UP INCLUDED A 250ML BAG OF NORMAL SALINE SPIKED WITH A METER TUBING, WHICH WAS THEN ATTACHED TO FILTER. THE MEDICATION INVOLVED WAS REMICADE. IT WAS FURTHER REPORTED THAT TUBING SET-UP WAS REPLACED AND TREATMENT WAS RESUMED. TREATMENT HAD JUST STARTED WHEN THE ISSUE WAS NOTED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065008 ↗
• MalfunctionNov 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER. THE REPORTER STATED THAT THE CUSTOMER HAD A TUBE/SET THAT BROKE WHILE USING WITH A PATIENT. THE SET-UP INCLUDED A 100ML BAG OF NORMAL SALINE SPIKED WITH A METER TUBING, WHICH IS THEN ATTACHED TO FILTER. THE MEDICATION INVOLVED WAS ACTEMRA. THE TUBING/SET-UP WAS NOT REPLACED, THE LEAKAGE WAS NOTICED AT THE END OF THE TREATMENT. THE PATIENT HAD FALLEN ASLEEP AND DID NOT FEEL SHE WAS GETTING WET. THE REPORTER COULD NOT TELL HOW MUCH OF THE TREATMENT THE PATIENT HAD RECEIVED; THEY SENT THE PATIENT HOME WITH A SAMPLE PEN OF ACTEMRA TO USE IF SHE NOTICED SHE DID NOT HAVE THE NORMAL RELIEF AFTER TREATMENT. NO MEDICAL INTERVENTION WAS REQUIRED AT THAT POINT. THERE WAS NO HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048181 ↗

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-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-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-0242-2021 · Jul 6, 2020 · Terminated
  11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(
• Z-0237-2021 · Jul 6, 2020 · Terminated
  20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(1
• Z-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0209-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)45729
• Z-0231-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)1088770908
• 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-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.