ICU Medical 12514-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887709044470), received between Apr 24, 2019 and Dec 4, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Disconnection” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K100576); 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.

• MalfunctionDec 4, 2024Disconnection; Disconnection

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE EXTENSION SET BECOMES DISCONNECTED WHEN USING A POWER INJECTOR FOR A CT SCANNER. STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS DURING PATIENT USE. IT WAS WHILE CONTRAST WAS BEING INJECTED INTO THE IV TUBING PRIOR TO THE START OF A CT SCAN. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848536 ↗
• MalfunctionOct 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WAS FOUND TO HAVE BECOME DISCONNECTED DURING PATIENT USE. THE REPORTER STATED THAT THE CONNECTORS WOULD NOT STAY CONNECTED. PATIENT MR# (B)(6) WAS INVOLVED IN THE EVENT. IT WAS ALSO STATED THAT THEY WERE NOT ABLE TO INJECT THE CORRECT AMOUNT OF CONTRAST AND THE NURSE ASSURED THAT THE CONNECTOR WAS HOOKED UP PROPERLY AND TIGHT. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT, AND NO DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558744 ↗
• MalfunctionOct 15, 2024Disconnection; Infusion or Flow Problem; Disconnection; Infusion or Flow Problem

  IT WAS REPORTED THAT A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WAS FOUND TO HAVE DISCONNECTED DURING PATIENT USE. THE REPORTER STATED THAT THEY WERE HAVING TROUBLE WITH THEIR EXTENSION SETS SINCE IT WAS NOT CONNECTING CORRECTLY OR COMING UNCONNECTED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452382 ↗
• MalfunctionAug 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WITH A POSSIBLE LOT NUMBER 13959618. THE REPORTED ISSUE INVOLVED DIFFICULTY IN CONNECTING OR TIGHTENING THE CONNECTORS OF THE DEVICE, WHICH RESULTED IN LEAKING FROM THE IV SET. EVIDENCE OF LEAKS WERE OBSERVED BENEATH THE TEGADERM STICKER USED TO COVER THE IV AND CONNECTOR. THE PATIENT WAS RECEIVING A CT SCAN VIA AN APEX CT SCANNER IN THE EMERGENCY ROOM -C POD AT THE FACILITY. THERE WAS PATIENT INVOLVEMENT, BUT NO HUMAN HARM AND NO DELAY IN THERAPY. THERE WERE 20 INCIDENTS THAT OCCURRED- THIS CAPTURES THE THIRD OF 20 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905622 ↗
• MalfunctionJun 30, 2024Disconnection; Disconnection

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. EMERGENCY ROOM NURSES AT THE FACILITY REPORTED THAT THIS DEVICE WAS COMING LOOSE EVEN AFTER TIGHTENING THEM DOWN, OR IT IS DIFFICULT TO THREAD/TIGHTEN DOWN. THE DEVICES ARE REPORTEDLY COMING UNDONE WHILE HAND-PUSHING UNSPECIFIED MEDICATION. THERE WAS NO REPORT OF HUMAN HARM. THIS REPORT REPRESENTS ONE OF THREE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640822 ↗
• MalfunctionJun 21, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  AN EVENT THAT OCCURRED ON AN UNKNOWN DATE INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER THAT HAD FREE FLOW OF INFUSION. IT WAS REPORTED THAT, NURSES STATED THEY HAVE A LOT OF TROUBLE CLAMPING THE LINE DUE TO THE STIFF TUBING AND HAVE TO USE TWO HANDS TO PUSH THE SLIDE CLAMP. THEY ALSO STATED ONCE CLAMPED, IT DIDN¿T FULLY CLOSE THE LINE AND FLUID WAS STILL ABLE TO GET THROUGH. MANY TIMES NURSES AREN¿T FOLLOWING CLAMPING PROTOCOL DUE TO HOW DIFFICULT IT IS TO CLAMP THE LINE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590271 ↗
• MalfunctionJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT, NURSES STATED THEY HAVE A LOT OF TROUBLE CLAMPING THE LINE DUE TO THE STIFF TUBING AND HAVE TO USE TWO HANDS TO PUSH THE SLIDE CLAMP. THEY ALSO STATED ONCE CLAMPED, IT DIDN¿T FULLY CLOSE THE LINE AND FLUID WAS STILL ABLE TO GET THROUGH. MANY TIMES, NURSES AREN¿T FOLLOWING CLAMPING PROTOCOL DUE TO HOW DIFFICULT IT IS TO CLAMP THE LINE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587936 ↗
• MalfunctionJun 17, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  REPEAT COMPLAINT REC'D REGARDING AN UNKNOWN QTY. OF (B)(4), 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET; LOT# 31-488-SL (MFG. DATE 07/2013) AND 31-495-SL (MFG. DATE 07/2013). THE REPORT STATES, "THE NEW EXTENSION SET IS MUCH HARDER TO SEAT INTO THE IV JELCO CATHETER, AND MANY TIMES REQUIRES A TWO HANDED TECHNIQUE. THE INCREASED MANIPULATION IS COMPROMISING THE IV CATHETER, AND IF NOT SEATED PROPERLY WILL CAUSE LEAKING AROUND THE CONNECTION." NO ADVERSE PATIENT CONSEQUENCES REPORTED. LOT ANALYSIS: A REVIEW OF THE MFG. LOT DATABASE FOR LOT#S 31-488-SL (MFG. DATE 07/2013), AND LOT# 31-495-SL (MFG. DATE 07/2013) SHOWS EACH LOT OF (B)(4) UNITS WAS MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THERE WAS NO EXCEPTION DOCUMENTATION GENERATED DURING ANY OF THE MFG. LOT BUILDS. MFG INVESTIGATION/ANALYSIS: MFG REC'D FIVE (5) NEW/ UNUSED 12514-01, EXT SETS; LOT# 31-488-SL (2), 30-574-SJ (1) AND 31-495-SL (2). ALSO REC'D SIX (6) NEW/UNUSED SMITH MEDICAL JELCO 20 (3) AND 22 (3) GAUGE PROTECT IV PLUS SAFETY CATHETERS THAT WERE VISUALLY INSPECTED WITH NO ANOMALIES PRESENT. ALL DEVICES MET REQUIRED ISO STANDARD SPECIFICATIONS FOR LUER TAPERS, ISO 594-1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554768 ↗
• MalfunctionMay 16, 2024Separation Problem; Separation Problem

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE EXTENSION SET AND/OR MALE LUER POPS OFF THE SMITH¿S CATHETER FEMALE LUER DURING COMPUTED TOMOGRAPHY (CT) INJECTION. THIS IS INTERMITTENT, BUT THEY HAVE SEEN AN INCREASE. THEY WANT TO VERIFY THAT ALL ITEMS ARE IN SPECIFICATION AND VALIDATE UNDER HIGH PRESSURE INJECTION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM AND THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE EVENT WAS AN ONGOING ISSUE IN MARCH/APRIL. THE EVENT OCCURRED AT CT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337173 ↗
• MalfunctionAug 29, 2023Separation Problem; Separation Problem

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE COMPUTED TOMOGRAPHY (CT) TECHS ARE HAVING PROBLEMS WHEN THEY ARE GIVING PATIENTS INTRAVENOUS (IV) CONTRAST. THEY THINK IT HAS TO DO WITH THE THREADS ON THE DEVICE. WHEN THEY ARE GIVING THE IV CONTRAST DYE TO THE PATIENT, THE PIECE WILL POP OFF OF THE IV SITE AND CONTRAST WILL GO EVERYWHERE. THE TECH SAID SHE HAS HAD THIS HAPPEN ON MULTIPLE OCCASIONS AND WHEN IT FIRST OCCURRED, SHE STARTED CHECKING TO ENSURE THE CONNECTIONS WERE TIGHT THINKING THAT MAY BE THE PROBLEM, BUT SHE SAID THAT DOESN¿T APPEAR TO BE THE ISSUE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645286 ↗
• MalfunctionApr 24, 2019Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER, WHERE THE CLAVE CAME OFF JUST AFTER THE IV START AND BLOOD BACKED UP THROUGH THE TUBING AND LEAKED FROM THE END. THE NURSE IMMEDIATELY CLAMPED THE TUBING AND REPLACED IT. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546465 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100576. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-1720-2022 · Aug 1, 2022 · Open, Classified
  8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
• Z-0193-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouche
• Z-0197-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multi
• Z-0201-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case.
• Z-0192-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 mul
• Z-0204-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per
• Z-1916-2020 · Oct 4, 2019 · Terminated
  REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889