ICU Medical 12512-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709050532), received between Aug 14, 2019 and Oct 25, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

52 other recalls cover devices cleared under the same FDA submission (K970855); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE CLEAR NEUTRAL CONNECTOR WHERE IT WAS REPORTED THE CONNECTOR CONTINUES TO COME DETACHED FROM THE INTRAVENOUS (IV) TUBING. CAPS ARE COMING OFF OF CENTRAL LINES WHICH COULD CAUSE PATIENT HARM. THERE WAS PATIENT INVOLVEMENT, NO ONE WAS HARMED AND THERE WAS A DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534845 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE® CLEAR NEUTRAL CONNECTOR. IT WAS REPORTED THAT AN INJECTION CAP (MICROCLAVE CLEAR) THAT WAS ON A PATIENT AND CONNECTED TO A PORT THAT HAD CHEMO INFUSING AT HOME. WHEN THEY WENT TO DISCONNECT THE PUMP FROM THE PATIENT ON FRIDAY, THEY NOTED CRYSTALLIZATION BETWEEN THE INJECTION CAP AND PORT, WHICH INDICATES THAT THE CHEMO INFUSING HAD LEAKED OUT. IT WAS ALSO STATED THAT THE DRUG USED WAS FLUOROURACIL (5FU). THEY USED PHASEAL AND THIS HAPPENED ABOVE THE CLOSED SYSTEM BETWEEN WHERE THE INJECTION CAP CONNECTS TO THE HUBER NEEDLE TUBING COMING FROM THE PATIENT. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075292 ↗
• MalfunctionAug 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE INTRAVENOUS (IV) TUBING WAS LEAKING DURING PATIENT USE IN THE EMERGENCY ROOM - SRU. THE CUSTOMER FURTHER REPORTED DIFFICULTY IN CONNECTING OR TIGHTENING THE CONNECTORS OF THE DEVICE, WHICH RESULTED IN THE LEAKAGE. THERE WAS EVIDENCE OF LEAKAGE OBSERVED BENEATH THE TAGADERM STICKER USED TO COVER THE IV AND CONNECTOR. THE DATA WAS COLLECTED BY THE STAFF ER APEX CT SCANNER; THERE WAS NO REPEAT TEST PERFORMED. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19899203 ↗
• MalfunctionAug 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE INTRAVENOUS (IV) TUBING WAS LEAKING DURING PATIENT USE IN THE EMERGENCY ROOM - C POD. THE CUSTOMER FURTHER REPORTED DIFFICULTY IN CONNECTING OR TIGHTENING THE CONNECTORS OF THE DEVICE, WHICH RESULTED IN THE LEAKAGE. THERE WAS EVIDENCE OF LEAKAGE OBSERVED BENEATH THE TAGADERM STICKER USED TO COVER THE IV AND CONNECTOR. THE DATA WAS COLLECTED BY THE STAFF ER APEX CT SCANNER; THERE WAS NO REPEAT TEST PERFORMED. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19898679 ↗
• MalfunctionAug 8, 2023No Flow; No Flow

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT IT CONTINUES TO BE CLOGGED OR HAVE GREAT RESISTANCE WHEN ACCESSING IT AND IT HAS BEEN OCCURRING FOR SOME TIME. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480969 ↗
• MalfunctionAug 14, 2019Disconnection; Disconnection

  THE EVENT INVOLVED A MICROCLAVE® CLEAR NEUTRAL CONNECTOR THAT WAS REPORTED TO COME OFF THE LINE WHEN THE HUB WAS SCRUBBED OR A FLUSH WAS DONE WHEN THE FLUSH IS SCREWED ON USING A THREADED LUER SLIP. THE PATIENT WAS RESTLESS THE NIGHT OF THE OCCURRENCE AND COBAND WAS USED TO PROTECT THE LINE SO IT WOULD NOT COME OFF. IT WAS REPORTED THE CONNECTOR DISCONNECTED FROM THE MALE END OF THE MICROCLAVE EVEN WITH COBAND COVERING THE SITE. THE LINE WAS BEING USED FOR ROUTINE CHEMOTHERAPY AND LAB DRAWS WITH FLUSHES. THERE WAS NO BLOOD LOSS REPORTED. IT WAS ALSO REPORTED THAT THE IV THERAPY NURSE FOUND THE CLAVE ATTACHED TO THE LINE OF AN INTERMITTENT INFUSION. THE CUSTOMER STATED THAT THE PATIENT SUSTAINED AN INFECTION AND THERE WAS A DELAY OF MANY HOURS TO REPLACE THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE BECAUSE THE CLAVE WAS MISSING.

  Patient problems: Unspecified Infection

  MAUDE report 8893651 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970855. One submission often covers many models, so check the product and lot details in each record.

• Z-1722-2022 · Aug 1, 2022 · Open, Classified
  MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration S
• Z-0685-2014 · Dec 24, 2013 · Terminated
  10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-0
• Z-0688-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic d
• Z-0679-2014 · Dec 24, 2013 · Terminated
  8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
• Z-0687-2014 · Dec 24, 2013 · Terminated
  78" Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is
• Z-0704-2014 · Dec 24, 2013 · Terminated
  28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a sin
• Z-0699-2014 · Dec 24, 2013 · Terminated
  120" 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needle
• Z-0700-2014 · Dec 24, 2013 · Terminated
  5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic
• Z-0675-2014 · Dec 24, 2013 · Terminated
  87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave, Part No. A1000, Item No. A1078 The ICU Needl
• Z-0680-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile,
• Z-0676-2014 · Dec 24, 2013 · Terminated
  13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-py
• Z-0707-2014 · Dec 24, 2013 · Terminated
  17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector
• Z-0682-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The ICU Needleless Connector is a single use, s
• Z-0672-2014 · Dec 24, 2013 · Terminated
  8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyr
• Z-0674-2014 · Dec 24, 2013 · Terminated
  10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device

…and 37 more.