ICU Medical 15247-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887709102057), received between May 21, 2025 and Sep 18, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3156-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829470 ↗
• MalfunctionSep 18, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829261 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak

  THE RUBBER PART IN THE BLUE CLAVE OF A 'PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH' GOT STUCK, THE NURSE WASN'T ABLE TO BACK PRIME AND THEN NORMAL SALINE SPILLED OUT FROM THE BLUE CLAVE DURING A PATIENT'S INFUSION. THIS OCCURRED WHEN SECONDARY TUBING WAS UNATTACHED; THE SMALL RUBBER PART IN BLUE CLAVE POPPED OUT AS WELL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056640 ↗
• MalfunctionApr 16, 2026No Flow

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH AND IT WAS REPORTED THAT THE RUBBER STOPPER SEAL INSIDE THE BLUE CLAVE ATTACHED TO THE PRIMARY PLUM TUBING SET GETS STUCK AND DOES NOT ALLOW FOR BACK PRIMING OR PROPER INFUSION OF MEDICATION FROM SECONDARY CASSETTE. THE PROBLEM USUALLY OCCURRED DURING INFUSION SPECIFICALLY WHEN BACK PRIMING PRIMARY FLUID INTO SECONDARY TUBING. THE MEDICATION THAT WAS INVOLVED ARE NORMAL SALINE 0.9% AND DEXTROSE 5% THERE WAS DELAY IN THERAPY EACH TIME THIS HAPPENED IT CAUSES AROUND 5 ¿ 10 MINUTES OF PATIENT DELAYS WHILE THE NURSE GETS AN ENTIRELY NEW SET OF PRIMARY AND SECONDARY TUBING. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893008 ↗
• MalfunctionFeb 24, 2026Device Contamination with Chemical or Other Material

  AN EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH REPORTED THAT A BROWN SUBSTANCE ON THE INSIDE OF THE DROP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427303 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH. THE CUSTOMER STATED THAT WHEN CHANGING THE CUSTOM TPN BAG FOR FLUID CHANGES FOR A PATIENT, THE PRIMARY SET WAS REPORTEDLY LEAKING TPN AT THE CHAMBER VALVE. SIGNIFICANT LEAKAGE WAS OBSERVED DOWN THE CHAMBER AND TUBING. THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794574 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE ((B)(6) 2025 USED AS PLACEHOLDER) AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE THE CUSTOMER REPORTED THAT THE IV LINE LEAKING AT THE VENT PORT. IT WAS UNKNOWN IF 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 23583362 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH THAT EXPERIENCED LEAKAGE DURING USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT HAS LEAKING FROM THE VENT PORT NEAR THE SPIKE WHILE PATIENT RECEIVING TPN. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804838 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH THAT EXPERIENCED LEAKAGE DURING USE. THE REPORTER STATED THAT THE IV TUBING LEAKING FROM VENT PORT. THE EVENT DATE WAS UNKNOWN. STATUS WAS UNKNOWN. THE PATIENT SAFETY WAS ISSUED AND MIDAS REPORT WAS MADE. THE IV TUBING WAS IN USE ON A PATIENT WHEN IT WAS NOTED TO BE LEAKING FROM THE VENT PORT. THE EXACT DATE OF THE INCIDENT WAS ON (B)(6) 2025. THE DEFECT RESULTED IN NO HARM TO THE PATIENT BUT DOES POSE A RISK FOR INFECTION AS IT WAS NO LONGER A CLOSED SYSTEM. THE SAMPLE IS AVAILABLE FOR EVALUATION. THUS, THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414482 ↗
• MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS REPORTED THE IV TUBING WAS LEAKING AT VENT PORT. THE IV TUBING WAS IN USE ON A PATIENT WHEN LEAKING WAS NOTICED AND PULLED FROM USE. THERE WAS NO HARM AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126220 ↗
• MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS REPORTED THE IV TUBING WAS LEAKING AT VENT PORT. THE IV TUBING WAS IN USE ON A PATIENT WHEN LEAKING WAS NOTICED AND PULLED FROM USE. THERE WAS NO HARM AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126219 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS REPORTED THE IV TUBING LEAKED AT VENT PORT. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064930 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS REPORTED THERE WERE 4 DEVICES THAT LEAKED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064797 ↗

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-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-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-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