ICU Medical 15339-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709102361), received between May 21, 2025 and May 23, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET WHERE IT WAS REPORTED THE IV TUBING WAS LEAKING IMMEDIATELY AFTER PRIMING/HANGING NEW LINE ON 4/23. IT WAS STATED MULTIPLE LINES HAVE LEAKED ON THE UNIT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078085 ↗
• MalfunctionMay 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET WHERE IT WAS REPORTED THE IV TUBING LEAKED AT THE VENT PORT IMMEDIATELY AFTER SPIKING A NEW BAG. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078082 ↗
• MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET WHERE THE CUSTOMER REPORTED IV TUBING IS LEAKING VANILLA TPN AT THE PORT DURING PATIENT USE IN THE NURSING DEPARTMENT. NEW TUBING HUNG AT 2217 AND NOTED TO BE LEAKING AT 23:30 ON 4/23. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071306 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, POLYETHYLENE-LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING IV FLUIDS OUT OF THE VENT LOCATED ON THE SPIKE OF THE TUBING ABOVE THE DRIP CHAMBER. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065529 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, POLYETHYLENE-LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THE DEVICE LEAKED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065054 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, POLYETHYLENE-LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED IV FLUIDS LEAKED FROM THE VENT PORT ABOVE THE DRIP CHAMBER. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064911 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON VARIOUS DATE IN APRIL 2025 AND INVOLVED A PRIMARY PLUM SET WHERE IT WAS REPORTED THERE WERE DEVICES WHICH LEAKED. THERE WAS NO ADVERSE EVENT. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064814 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, POLYETHYLENE-LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED TOTAL PARENTERAL NUTRITION (TPN) / IV FLUIDS LEAKED AROUND AND OUT OF THE VENT PORT ON THE SPIKE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064804 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, POLYETHYLENE-LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THE IV FLUIDS LEAKED FROM THE VENT ABOVE THE DRIP CHAMBER. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063550 ↗

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-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-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-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