ICU Medical 15687-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00887709102460), received between Jan 6, 2025 and Sep 3, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Contamination” (13 reports).

11 other recalls cover devices cleared under the same FDA submission (K141789); 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50585191 ↗
• MalfunctionJun 30, 2026Particulates

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128-INCH. IT WAS REPORTED THAT THE CUSTOMER INITIALLY PLACED AN OVERNIGHT ORDER FOR SUBSTITUTE ITEM 15687 AFTER REPORTING BLACK SPECKS IN ITEM 14687. THE SUBSTITUTE ITEM WAS LATER FOUND TO HAVE THE SAME ISSUE. THE CUSTOMER THEN FELT COMFORTABLE USING THE CURRENT PRODUCT AND REQUESTED TO RETURN THE SUBSTITUTE ITEMS. THE CAMERA RESOLUTION DID NOT CAPTURE THE SPECS. THERE WAS NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670786 ↗
• MalfunctionJun 18, 2026Particulates

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCH THAT THE CONTAMINATION WAS REPORTED AS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS AND HAS BEEN REPORTED IN NUMEROUS LOTS ACROSS THREE PRODUCT TYPES FROM ICU MEDICAL. IN SOME PRODUCTS, PARTICULATE MATTER APPEARS IN THE LUMEN OR CHAMBER OF THE TUBING. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL BUT NOT WITHIN THE LUMEN OR CHAMBER. NO ADVERSE EVENTS HAVE BEEN LINKED TO THE PRODUCTS, AND THE BIOLOGICAL NATURE OF THE PARTICULATES REMAINS UNKNOWN. THE EVENT OCCURRED PRIOR TO PATIENT USE AND UPON INSPECTION OF THE PRODUCT. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553017 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES TWELVE OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25517158 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES TEN OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516965 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES EIGHT OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516957 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES SEVEN OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516946 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES FOURTEEN OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516742 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES ELEVEN OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516550 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES SIX OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516436 ↗
• MalfunctionJun 16, 2026Contamination /Decontamination Problem

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES FOUR OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515745 ↗
• MalfunctionJun 16, 2026Contamination /Decontamination Problem

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES THREE OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515736 ↗
• MalfunctionJun 16, 2026Contamination

  TWENTY-ONE NEW, UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OF WHICH FOURTEEN WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT CAPTURES TWO OF FOURTEEN DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515715 ↗
• MalfunctionJun 16, 2026Contamination

  AN EVENT INVOLVING A PRIMARY PLUM SET REPORTED THAT IV TUBING SET WAS FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL AND NOT WITHIN THE LUMEN OR CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514842 ↗
• MalfunctionJun 15, 2026Contamination

  AN EVENT INVOLVING PRIMARY PLUM SET REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS FOUND INSIDE THE DRIP CHAMBER AND ALSO FOUND INSIDE THE AREA WHERE THE DRIP CHAMBER WAS NARROWED INTO THE TUBING AS WELL AS THE SMALLER CHAMBER JUST ABOVE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500542 ↗
• MalfunctionJun 15, 2026Contamination

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCH, AND IT WAS REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS FOUND INSIDE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499156 ↗
• MalfunctionJun 9, 2026Contamination

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCHES, AND IT WAS REPORTED A SMALL BLACK DOT ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441137 ↗
• MalfunctionJun 8, 2026Particulates

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY PLUM SET WITH CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128-INCH TUBING. IT WAS REPORTED THAT SOME SETS INTENDED FOR SHIPMENT HAD A WHITE FILM IN THE DRIP CHAMBER. THE CUSTOMER HAS BEEN INSPECTING EACH SET PRIOR TO USE AND IDENTIFIED THAT THE FILM WAS PRESENT IN MANY DRIP CHAMBERS. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 05/15/2026 INDICATED THAT THE CUSTOMER WOULD BE SENDING ADDITIONAL SAMPLES WITH DENTS, SCRATCHES, OR OTHER DEFORMITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428269 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCH IN WHICH IT WAS REPORTED THE DEVICE LEAKED AT THE Y-SITE. IT WAS REPORTED THAT THE REGISTERED NURSE (RN) STATED THE TUBING ON L1 OF THE DEVICE HAD BEEN HUNG ON (B)(6) 2026 AT 05:17 WITH VASOPRESSIN RUNNING AT 0.03 U PER MIN (4.5 ML PER HR) DURING THE DAY SHIFT. ON (B)(6) 2026, THE CLINICAL COORDINATOR NOT THE BEDSIDE RN REPORTED THAT THE PATIENT VITALS REQUIRED THE ADDITION OF ANOTHER MEDICATION, PHENYLEPHRINE, WHICH WAS CONNECTED TO THE Y-SITE ON THE TUBING. ACCORDING TO THE RN, THE PHENYLEPHRINE INFUSION HAD TO BE TITRATED FROM 20 MCG PER MIN TO 250 MCG PER MIN BETWEEN 16:30 AND 18:35, AT WHICH TIME IT WAS DISCOVERED THAT THE TUBING WAS LEAKING AT THE Y-SITE. THE TUBING WAS REPLACED AT THAT TIME. THE CLINICAL COORDINATOR CONFIRMED THE LEAK BY ATTACHING A BAG OF SALINE AND OBSERVED FLUID LEAKING BELOW THE BONDED CLAVE AT THE LOWER Y-SITE. THE PATIENT WAS REPORTED TO BE STABLE AS OF (B)(6) 2026 AT 09:45. IT WAS UNCLEAR IF THERE WAS ANY IMPACT TO THE PATIENT AT THE TIME OF THE EVENTS ON 18-MAR-2026, AS THE REPORTING RN STATED THAT THE PATIENT¿S CONDITION REQUIRED MULTIPLE ME

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24750073 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 4 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER, 15 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, SECURE LOCK, 216 CM. A LEAK OF 5% GLUCOSE ON THE 4V RINSING SHAFT WAS REPORTED DURING USE ON A PATIENT. THERE WERE NO ADVERSE CLINICAL CONSEQUENCES AND NOBODY WAS INJURED. THERE WAS NO DELAY IN THERAPY AND THIS ONE WAS COMPLETED. THERE WAS NO BLOOD LOSS CONSIDERED CLINICALLY SIGNIFICANT. THE PATIENT RECEIVED THE FULL INTENDED DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877721 ↗
• MalfunctionMar 8, 2025No Flow; No Flow

  IT WAS REPORTED THAT A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCH WAS FOUND TO HAVE BEEN OCCLUDED DURING PATIENT USE. IT WAS REPORTED THAT THEY ARE EXPERIENCING PROXIMAL OCCLUSION DUE TO BACK PRIMING. THE EVENT OCCURRED DURING INFUSION OF DILAUDID. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556102 ↗
• MalfunctionJan 6, 2025Fluid/Blood Leak; Free or Unrestricted Flow; Fluid/Blood Leak; Free or Unrestricted Flow

  IT WAS REPORTED THAT A PRIMARY PLUM SET, 4 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER, 15 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, SECURE LOCK, 216 CM HAD A LEAK ISSUE. IT WAS STATED THAT ¿INFUSION WAS SET UP CORRECTLY FROM ONE OF THE CONNECTION PORTS, BUT THE DRUG BEING INFUSED WAS COMING OUT OF ANOTHER PORT THAT WAS NOT IN USE. THE PROBLEM WAS ONLY HIGHLIGHTED ON ONE DEVICE OF THE INDICATED BATCH.¿ SAMPLE PICTURE WAS NOT PROVIDED. DRUG USED: CICLOFOSFAMIDE. THE LEAK OCCURRED FEW MINUTES AFTER THE INFUSION STARTED. THE PUMP WAS SET AT 125 ML/H. THE PUMP DID NOT ALARM. THE PLUM SET HAS BEEN REMOVED AND DISCARDED ACCORDING TO THE PROCEDURE. NO BLOOD LOSS CONSIDERED CLINICALLY SIGNIFICANT. THE SET WAS REPLACED, THERAPY RESUMED, THE INFUSION CONTINUED. A RETRACTED VALVE WAS DETECTED. THE LEAK DID NOT COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROFESSIONAL. THE LEAK WAS MANAGED AS PER INTERNAL PROCEDURE ( SPILL KIT USED). THE DEVICE INVOLVED WAS DISCARDED. THE EVENT OCCURRED DURING PATIENT USE, NO ADVERSE EVENT, NO HUMAN HARM, NO NEED FOR MEDICAL INTERVENTION. THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21082918 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141789. One submission often covers many models, so check the product and lot details in each record.

• Z-3162-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-2447-2024 · May 7, 2024 · Open, Classified
  Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following de
• Z-2430-2023 · Jul 13, 2023 · Open, Classified
  Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 3001010
• Z-1565-2023 · Mar 22, 2023 · Open, Classified
  Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
• Z-0127-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Line
• Z-0145-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Mic
• Z-0128-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Mic
• Z-3031-2017 · Jun 15, 2017 · Terminated
  Plum 360 Infusion System
• Z-1682-2017 · Dec 30, 2016 · Terminated
  Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
• Z-1833-2016 · Mar 25, 2016 · Terminated
  The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With it
• Z-1832-2016 · Mar 25, 2016 · Terminated
  The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver