Plum 1233912Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10887787005315), received between Jun 5, 2019 and Sep 28, 2026 — classified as 131 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (108 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 12, 2026Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 131 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 50924633 ↗
• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794831 ↗
• MalfunctionSep 8, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670365 ↗
• MalfunctionJun 3, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THAT THE FILTER VENT WAS SUSPECTED OF LEAKING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383539 ↗
• MalfunctionMar 15, 2026Fluid/Blood Leak

  LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED AT THE FILTER VENT OF THE FOLLOWING DEVICE: PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH. THE CUSTOMER STATED THAT, ALTHOUGH THE PROBLEM OCCURRED DURING PATIENT USE, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601653 ↗
• MalfunctionMar 14, 2026Fluid/Blood Leak

  LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED AT THE FILTER VENT OF THE FOLLOWING DEVICE: PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH. THERE WAS A PATIENT INVOLVED IN THE REPORTED EVENT; HOWEVER THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600390 ↗
• MalfunctionMar 13, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE A LEAKAGE AT THE FILTER VENT DURING INFUSION WAS REPORTED. CARBOPLATIN WAS INVOLVED IN THE EVENT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594983 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS STATED IN THE REPORT THAT ON THE SECOND DAY OF 5-FU ADMINISTRATION, THE FILTER VENT COVER WAS FOUND LEAKING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444342 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH REPORTED THAT AFTER INFUSING ELOXATIN FOR 4 HOURS AND THEN INFUSING 5-FU (FLUOROURACIL) FOR ABOUT 9 HOURS, LEAKAGE OCCURRED AT FILTER VENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265157 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH REPORTEDLY LEAKED AN UNSPECIFIED FLUID/INFUSATE AT THE TUBING LOCATION DURING A PATIENT'S INFUSION. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264662 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE FROM THE DRIP CHAMBER OF A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WAS REPORTED DURING A PATIENT'S INFUSION. THERE WAS NO UNPROTECTED CHEMO EXPOSURE AND THERE WAS NO HARM TO THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262124 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH REPORTED THAT THE FILTER VENT LEAKED AFTER IRINOTECAN HAS BEEN INFUSING FOR 2.5 HOURS. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186440 ↗
• MalfunctionJan 16, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THERE WAS A LEAK AT THE FILTER VENT. NO DRUG WAS INVOLVED IN THE EVENT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093623 ↗
• MalfunctionDec 22, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  AN EVENT INVOLVING A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH. IT WAS REPORTED THAT ON THE SECOND DAY OF USE, THE CHEMO DRUG LEAKED DUE TO THE LUER WAS BROKEN DURING INFUSION. TOXOL AND CISPLATIN WAS INVOLVED IN THE EVENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861490 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA EMAIL THAT A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH, ALLEGING A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT A LEAKAGE WAS NOTED IMMEDIATELY AFTER INFUSION STARTED. TAXOTERE WAS INVOLVED AND INFUSED AT A FLOW RATE OF 128ML/HR. THERE WAS NO CHEMOTHERAPY EXPOSURE AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831581 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCHES REPORTED THAT LEAKAGE AT THE FILTER VENT. AN UNKNOWN DRUG WAS INVOLVED IN THE EVENT. EVENT WAS NOTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARMED. THERE WAS NO CHEMOTHERAPY EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824986 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN INCIDENT INVOLVING A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH REPORTED THAT LEAKAGE WAS NOTED AT FILTER VENT AFTER 0.2 HOURS OF INFUSION. VENT CAP WAS CLOSED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824956 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH REPORTED THAT THE LIQUID LEAKS FROM THE FILTER VENT EVEN WHEN IT IS IN THE CLOSED POSITION DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM / INJURY. UNKNOWN DRUG WAS INFUSED AND THERE WAS NO CHEMO EXPOSURE. TWO OCCURRENCES WERE REPORTED. NO ADDITIONAL DISTINGUISHING DETAILS OR DIFFERENTIATING INFORMATION WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813081 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCHES GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT LEAKAGE AT THE FILTER VENT. CISPLATIN WAS INVOLVED IN THE EVENT. THE EVENT WAS NOTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT WAS HARMED. THERE WAS NO CHEMOTHERAPY EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811184 ↗
• MalfunctionDec 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN INCIDENT INVOLVING A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH REPORTED THAT LEAKAGE AT THE FILTER VENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799935 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE THE CUSTOMER REPORTED THAT THERE WERE WATER DROPS ON THE FILTER VENT. THE DRUG NAME WAS UNKNOWN; THERE WAS NO REPORT OF DRUG EXPOSURE. 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 23739350 ↗
• MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVING PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCHES REPORTED THAT THE CLAVE AND THE AIR VENT'S TIP WOULD DRIP AND THE AIR VENT WASN'T EVEN OPEN. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712726 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE THE CUSTOMER REPORTED THAT ON THE FOURTH DAY OF THE CHEMICAL INJECTION PROCEDURE, THE FILTER VENT WAS FOUND TO BE LEAKING ETOPOSIDE. THERE WAS NO CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597453 ↗
• MalfunctionOct 15, 2025Crack; Crack

  THE EVENT INVOLVED A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCHES WHERE IT WAS REPORTED THAT THE CLAVE CRACKED. THE PATIENT INVOLVEMENT WAS UNKNOWN, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295223 ↗
• MalfunctionSep 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IS WAS STATED IN THE REPORT THAT "THE PRODUCT WOULD DRIP LEUCOVORIN FROM THE FILTER VENT DURING INFUSION." THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS ONE (1) DEVICE QUANTITY AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021617 ↗

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