Plum 1425628Recalls & reported problems

Summary

The FDA's MAUDE database contains 204 adverse event reports that list this exact device (DI 10887787005230), received between Feb 19, 2019 and Sep 28, 2026 — classified as 3 injuries, 201 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (183 reports).

1 FDA recall record name this device's identifier.

10 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 29, 2019Terminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0127-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 204 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923546 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859787 ↗
• MalfunctionJun 20, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WAS STATED IN THE REPORT THAT CONNECTING THE SET FILTER TO THE INFUSION SET, FLUID WAS LEAKING FROM THE JOINT BELOW THE DRIP CHAMBER, AND THREE DROPS OF FLUID DRIPPED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25571651 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS STATED IN THE REPORT THAT CHEMOTHERAPY (KEYTRUDA+CISPLATIN+ETOPOSIDE) WAS ADMINISTERED FROM 21 APRIL TO 23 APRIL. ON 23 APRIL, AFTER COMPLETION OF CHEMOTHERAPY, LEAKAGE FROM THE FILTER WAS FOUND. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216962 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH REPORTED THAT A LEAKAGE AT FILTER VENT DURING INFUSION. MANNITOL WAS INVOLVED IN THE EVENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001599 ↗
• MalfunctionApr 24, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE A 0.2UM FILTER LEAKAGE OF AN UNKNOWN CHEMO DRUG DURING INFUSION WAS REPORTED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990837 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH AND IT WAS REPORTED THAT THERE WAS CONTINUOUS LEAKAGE OF IV FLUID FROM THE FILTER VENT. PATIENT INVOLVEMENT IS UNKNOWN; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643203 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH AND IT WAS REPORTED THAT THE FILTER WAS LEAKING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603183 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE THE CUSTOMER REPORTED THAT THE DEVICE LEAKED AT THE FILTER VENT. NO DRUG WAS INVOLVED IN THE EVENT. PATIENT INVOLVEMENT IS UNKNOWN; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527176 ↗
• MalfunctionFeb 20, 2026Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH IN WHICH IT WAS REPORTED THAT THERE IS AN UNKNOWN CAUSE OF LEAKAGE DURING PATIENT'S IV INFUSION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408090 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE TOTAL PARENTERAL NUTRITION (TPN) SOLUTION LEAKED AT THE PREPIERCED Y-SITE DURING INFUSION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339787 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH IN WHICH IT WAS REPORTED THAT MEDICATION LEAKED FROM THE FILTER VENT WHEN THE VENT CAP WAS NOT OPENED DURING USE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299655 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  THE DRIP CHAMBER OF A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCHES REPORTEDLY LEAKED AN UNSPECIFIED CHEMOTHERAPY DRUG DURING A PATIENT'S INFUSION. THERE WERE NO DEFECTS NOTED ON THE PRODUCT. THE PRODUCTS WERE STORED IN AN AIR-CONDITIONED ROOM. THERE WAS NO DELAY IN CRITICAL THERAPY AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250287 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCHES REPORTED THAT LEAKAGE FROM CONNECTOR. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244514 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH REPORTED THAT A LEAK WAS OBSERVED AT THE FILTER VENT DURING CHEMOTHERAPY DRUGS INFUSION. AN UNKNOWN CHEMO DRUG WAS INVOLVED IN THE EVENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197852 ↗
• MalfunctionJan 22, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE THE CUSTOMER REPORTED THAT A LEAK WAS OBSERVED AT THE FILTER VENT DURING INFUSION. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151492 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS REPORTED THERE WAS A LEAK AT TUBING CONNECTOR. NO DRUG WAS INVOLVED IN THE EVENT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARMED. THERE WAS NO UNPROTECTED DRUG EXPOSURE TO PATIENT OR HEALTHCARE PROVIDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24062541 ↗
• MalfunctionJan 4, 2026No Flow

  AN EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH REPORTED THAT THE PUMP FAILS TO DELIVER THE MEDICATION INTO THE INFUSION SET. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954407 ↗
• MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH IN WHICH IT WAS STATED IN THE REPORT THAT THE FILTER WAS LEAKING. NO DRUG WAS INVOLVED IN THE EVENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873584 ↗
• MalfunctionDec 12, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT INVOLVED THE FOLLOWING DEVICE: PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH. THE Y-SITE PIERCED CAP REPORTEDLY FELL OFF, CAUSING LEAKAGE OF AN UNSPECIFIED CHEMOTHERAPY DRUG DURING USE ON A PATIENT. THERE WAS NO DRUG EXPOSURE. THERE WERE NO OBVIOUS DEFECTS NOTED ON THE PRODUCT. THE PRODUCTS WERE STORED IN AN AIR-CONDITIONED ROOM. THERE WAS NO HARM TO THE PATIENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794924 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS STATED IN THE REPORT THAT THERE WAS A LEAKAGE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408311 ↗
• MalfunctionSep 10, 2025Particulates; Particulates

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE IT WAS STATED IN THE REPORT THAT "THERE ARE STAINS AT CHAMBER." THERE WAS ONE QUANTITY AFFECTED. THE EVENT WAS NOTED DURING DRUG PREPARATION. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017145 ↗
• MalfunctionSep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH. IT WAS STATED IN THE REPORT THAT THE DRUG ETOPOSIDE WAS ADMINISTERED FROM (B)(6) 2025 TO (B)(6) 2025, ON THE THIRD DAY, IT WAS DISCOVERED THAT THE MEDICATION LEAKED FROM THE FILTER VENT, DRIPPING ALONG THE TUBING ONTO THE FLOOR. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED. THERE WAS NO UNPROTECTED CHEMO EXPOSURE TO PATIENT OR HEALTHCARE PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998800 ↗
• MalfunctionAug 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE THEY REPORTED LEAKAGE AT THE FILTER DURING PATIENT INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM AS A RESULT OF THIS EVENT. THERE IS ONE QUANTITY AFFECTED. UNKNOWN DRUG WAS USED AND NO UNPROTECTED DRUG EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923633 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, DISTAL MICROBORE TUBING, SECURE LOCK, 104 INCH WHERE THEY REPORTED THAT THERE WAS LEAKAGE NOTED AT THE PREPIERCED Y-SITE DURING INFUSION. THERE WAS ONE QUANTITY AFFECTED. THERE WAS UNKNOWN DRUG USED AND NO UNPROTECTED CHEMO EXPOSURE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841680 ↗

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-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