ICU Medical MC33917Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709071605), received between Nov 21, 2024 and Jan 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 7" SMALLBORE TRIFUSE EXT SET W/REMV 3 MICROCLAVE® CLEAR (GLOW, PURPLE RINGS), 3 CLAMPS, ROTATING LUER WHERE IT WAS REPORTED THAT THE HOSPITAL WAS STILL EXPERIENCING ISSUES WITH LEAKING FROM THE MICROCLAVE. THE REPORTER IDENTIFIED THAT THE BD 10011865 0.2-MICRON FILTER SET WAS AN INCOMPATIBLE MATING DEVICE AND THERE MAY BE ADDITIONAL FACTORS CONTRIBUTING TO THE LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085718 ↗
• MalfunctionNov 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" SMALLBORE TRIFUSE EXT SET W/REMV 3 MICROCLAVE® CLEAR (GLOW, PURPLE RINGS), 3 CLAMPS, ROTATING LUER THAT REPORTEDLY LEAKED AN UNSPECIFIED FLUID/INFUSATE AT THE BASE OF THE MICROCLAVE DURING PATIENT USE. INITIALLY THE FACILITY SUSPECTED THAT THE MICROCLAVE LEAKAGE WAS COMING FROM THE CONNECTION TO THE 1F VYGON PICC. THEY ALSO USE OTHER SIZES OF PICC BUT PRIMARILY THE 1F. UPON FURTHER REVIEW, THE LEAKAGE WAS OBSERVED FROM THE BASE OF THE MICROCLAVE, EVEN ON THE TRIFUSE EXTENSION SET. THE EVENT DATE IS ONGOING APPROXIMATELY FOR ONE CALENDAR YEAR. THERE WAS NO HUMAN HARM AND IT WAS UNKNOWN IF THERE WAS ANY DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767735 ↗
• MalfunctionNov 21, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON VARIOUS DAYS AND INVOLVED A 7" SMALLBORE TRIFUSE EXT SET W/REMV 3 MICROCLAVE® LEAR (GLOW, PURPLE RINGS), 3 CLAMPS, ROTATING LUER WHERE IT WAS REPORTED THAT IN THE PAST TWO WEEKS, THEY HAD INSTANCES OF CRACKED MICROCLAVES REPORTED IN THE NEONATAL INTENSIVE CARE UNIT (NICU). INITIALLY, THERE WAS CONCERN THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINES WERE CAUSING THE ISSUE, BUT CURRENT FEEDBACK POINTS TOWARD THE MICROCLAVES THEMSELVES AS THE SOURCE. THERE WERE COMPLAINTS OF CRACKING AT THE BASE OF THE MICROCLAVES. INITIALLY THEY SUSPECTED THE CRACKING OF THE MICROCLAVE WAS COMING FROM THE CONNECTING TO THE 1F VYGON PICC. THEY USE OTHER SIZES OF PICC BUT PRIMARILY THE 1F. IT WAS ALSO STATED THAT THEY TEASED THIS OUT AS THEY SEE THE LEAKING FROM THE BASE OF THE MICROCLAVE EVEN ON THE TRIFUSE EXTENSION SET. THE EVENT DATE IS ONGOING APPROXIMATELY FOR ONE CALENDAR YEAR. STATUS WAS DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN IN DELAY IN THERAPY. THIS CAPTURES 1 OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754448 ↗
• MalfunctionNov 21, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON VARIOUS DAYS AND INVOLVED A 7" SMALLBORE TRIFUSE EXT SET W/REMV 3 MICROCLAVE® LEAR (GLOW, PURPLE RINGS), 3 CLAMPS, ROTATING LUER WHERE IT WAS REPORTED THAT IN THE PAST TWO WEEKS, THEY HAD INSTANCES OF CRACKED MICROCLAVES REPORTED IN THE NEONATAL INTENSIVE CARE UNIT (NICU). INITIALLY, THERE WAS CONCERN THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINES WERE CAUSING THE ISSUE, BUT CURRENT FEEDBACK POINTS TOWARD THE MICROCLAVES THEMSELVES AS THE SOURCE. THERE WERE COMPLAINTS OF CRACKING AT THE BASE OF THE MICROCLAVES. INITIALLY THEY SUSPECTED THE CRACKING OF THE MICROCLAVE WAS COMING FROM THE CONNECTING TO THE 1F VYGON PICC. THEY USE OTHER SIZES OF PICC BUT PRIMARILY THE 1F. IT WAS ALSO STATED THAT THEY TEASED THIS OUT AS THEY SEE THE LEAKING FROM THE BASE OF THE MICROCLAVE EVEN ON THE TRIFUSE EXTENSION SET. THE EVENT DATE IS ONGOING APPROXIMATELY FOR ONE CALENDAR YEAR. STATUS WAS DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN IN DELAY IN THERAPY. THIS CAPTURES 2 OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754442 ↗

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-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-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-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-0196-2021 · Jul 6, 2020 · Terminated
  7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)2
• 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
• 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-0218-2021 · Jul 6, 2020 · Terminated
  126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01
• 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-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

…and 173 more.