ICU Medical SF3258-15HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840619046200), received between May 1, 2018 and Mar 19, 2019 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434809 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434742 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434703 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434636 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434609 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434568 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434477 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434366 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434252 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434214 ↗
• MalfunctionMar 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER CONTACT REPORTED THE TUBING SET IS LEAKING AN UNSPECIFIED CHEMOTHERAPY DRUG AT THE JUNCTION OF THE IV SET SPIKE AND BAG OR AT THE VENT. ADDITIONALLY, THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434117 ↗
• MalfunctionMay 2, 2018Leak/Splash

  SECONDARY TUBING LEAKING OUT VENT WITH IVIG WHEN CHANGING BOTTLES.

  Patient problems: No Information

  MAUDE report 7482465 ↗
• MalfunctionMay 1, 2018Leak/Splash

  IVIG SECONDARY TUBING LEAKING OUT VENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478897 ↗

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-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-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-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• Z-0217-2021 · Jul 6, 2020 · Terminated
  Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)
• 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-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-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-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• Z-0210-2021 · Jul 6, 2020 · Terminated
  13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)108

…and 173 more.