ICU Medical B9462Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887709013971), received between Nov 12, 2024 and Oct 15, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING LUER WHERE A LEAK WAS REPORTED. THE CUSTOMER SWITCHED THE TUBING AND WAS WORKING AFTER THAT. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM, BUT THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301641 ↗
• MalfunctionAug 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT AFTER STARTING THE IV, THEY ATTACH THE DEVICE TO THE HUB AND THEN THEY SAW BLOOD COMING UP THE TUBING. THE CUSTOMER STATED THAT THE FIRST TIME IT HAPPENED THEY THOUGHT THEY HAD MISTAKENLY HIT AN ARTERY. THE CUSTOMER ALSO REPORTED THAT IT BECOMES AN ISSUE WHEN THEY FLUSH THE LINE; FLUID "SQUIRTS" OUT OF THE EXTENSION FROM THE BLUE CLAMP END; IT APPEARS TO BE WHERE THE DISTAL PART OF THE TUBING ATTACHES TO THE CLAMP AND THEY TRIED TO CHANGE JUST THE CLAMP PIECE, BUT IT STILL OCCURRED. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687747 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE CUSTOMER USED SEVERAL OF THE ITEM FROM THE SAME BOX AND THEY WERE LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322583 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE DEVICE LEAKED FROM THE CONNECTION PIECE THREE TIMES. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062422 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THEY HAD ANOTHER IV EXTENSION SET LEAK FROM A DIFFERENT BOX THEY JUST OPENED. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING INJECTION OF RADIOISOTOPE. THE MEDICATION LEAKING AT THE TIME OF THE EVENT IS SALINE. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734982 ↗
• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE PRODUCT IS LEAKING. THE DEVICE LEAKED AT THE CLAVE CONNECTOR. THE EVENT OCCURRED DURING AN IV BEING SET FOR A PATIENT ON DIFFERENT OCCASIONS AND DIFFERENT BOXES. THERE WAS PATENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191048 ↗
• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING LUER THAT WAS REPORTEDLY LEAKING AT THE CLAVE CONNECTOR DURING AN IV SET UP FOR A PATIENT ON DIFFERENT OCCASIONS FROM DIFFERENT BOXES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190464 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING LUER WHERE IT WAS STATED IN THE REPORT THAT THE VALVE DOES NOT SIT TIGHTLY ON THE TUBING AND CAN BECOME DISLODGED. THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS NO DELAY IN THERAPY, BUT TECH HAD TO BE SENT TO THE ER FOR BLOOD EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21128906 ↗
• MalfunctionDec 12, 2024Crack; Leak/Splash; Material Puncture/Hole; Crack; Leak/Splash; Material Puncture/Hole

  THE EVENT OCCURRED ON VARIOUS DATES FROM OCTOBER TO (B)(6) 2024 AND INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE PRODUCT HAS HOLES IN THE TUBING AND BLOOD HAS SPRAYED EVERYWHERE MULTIPLE TIMES. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20913303 ↗
• MalfunctionDec 11, 2024Material Puncture/Hole; Material Puncture/Hole

  THE EVENT OCCURRED ON VARIOUS DATES FROM (B)(6) TO (B)(6) 2024 AND INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE PRODUCT HAS HOLES IN THE TUBING AND BLOOD HAS SPRAYED EVERYWHERE MULTIPLE TIMES. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20908927 ↗
• MalfunctionNov 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING LUER THE REPORTER STATED THAT AFTER SHE ATTACHED THE ITEM TO FLUSH OUT, THE IV WAS LEAKING FROM THE END THAT SHE ATTACHED THE SYRINGE. THE EVENT HAPPENED DURING USE ON A PATIENT. SALINE WAS LEAKING AT THE TIME OF THE INCIDENT AND BLOOD FLOWED DOWN TOWARDS THE END WHEN THE SYRINGE WAS ATTACHED. THIS ISSUE OCCURRED WHEN FLUSHING THE IV EXT SET. THERE WAS NO SALINE SOLUTION BAG INVOLVED. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENTS. THE NUMBER OF PRODUCT ISSUES OCCURRED WAS TWICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20670034 ↗

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-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-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-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• 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-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-0251-2021 · Jul 6, 2020 · Terminated
  60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Ad
• Z-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• Z-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)
• 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

…and 173 more.