Plum 1427329Recalls & reported problems

Summary

The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 10887787008804), received between Sep 20, 2019 and Sep 28, 2026 — classified as 1 injury, 213 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (94 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 214 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Environmental Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924374 ↗
• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888192 ↗
• MalfunctionSep 22, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862613 ↗
• MalfunctionSep 22, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860245 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859936 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859435 ↗
• MalfunctionSep 22, 2026Break

  An event involved a PLUM 150 mL Burette Set, CLAVE Injection Site, 2 CLAVE Y-Sites, SL. It was stated in the report during medication dosing through the burette, the CLAVE connector suddenly broke. There was patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858810 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699683 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak

  A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN THAT REPORTEDLY DRIPPED AN UNSPECIFIED CHEMOTHERAPY DOWNWARD, EVEN AFTER CLOSING THE AIR VENT DURING PATIENT ADMINISTRATION (AFTER PRIMING). THE CUSTOMER STATED THAT THE DRUG LEAKED OUT THROUGH THE CLAVE FROM THE FULL INFUSION BAG. THERE WAS NO PATIENT HARM AND NO UNPROTECTED CHEMOTHERAPY EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059729 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PLUMSET 3 CLV SITES 0.2 FLTR 112IN NDEHP. TOWARDS THE END OF A PATIENT'S INFUSION THROUGH A CENTRAL LINE, A LEAK WAS REPORTED FROM THE VENT ABOVE THE CHAMBER. THE MEDICATION INVOLVED IN THE INFUSION IS PACLITAXEL DILUTED IN NORMAL SALINE, INFUSED AT 265ML/HR AND THE CONCENTRATION OF THE MEDICATION IS 0.35MG/ML. THERE WAS NO PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004570 ↗
• MalfunctionApr 22, 2026No Flow

  THE EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WHERE IT WAS STATED IN THE REPORT THAT CANNOT ADD MEDICATION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957502 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WHERE IT WAS STATED IN THE REPORT THAT THERE WAS LEAKING AT IV CONNECTION SITE. THERE WAS NO PATIENT INJURY IN THE EVENT. OTHER INFORMATION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942349 ↗
• MalfunctionApr 7, 2026Crack

  EVENT OCCURRED REGARDING A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WHERE IT WAS STATED IN THE REPORT THAT WHEN THE NURSE WAS ADDING MEDICATION TO THE BURETTE, THE CONNECTOR BROKE. DRUG NAME WAS UNKNOWN. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801925 ↗
• MalfunctionMar 16, 2026Break

  A CLAVE OF THE FOLLOWING MEDICAL DEVICE: 'PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN' REPORTEDLY BROKE DURING A PATIENT'S INFUSION OF AN UNSPECIFIED FLUID/INFUSATE. THIS COULD LIKELY LEAD TO LEAKAGE. THE INVOLVED PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613418 ↗
• MalfunctionMar 13, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WHERE A LEAKAGE AT THE CLAVE WAS REPORTED. NORMAL SALINE WAS INVOLVED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593351 ↗
• MalfunctionMar 5, 2026No Flow

  THE EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WHERE THE CUSTOMER REPORTED THAT THE DEVICE CANNOT INFUSE THE UNSPECIFIED DRUG. 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 24527125 ↗
• MalfunctionFeb 18, 2026Break

  A COMPLAINT WAS RECEIVED REGARDING A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN IN WHICH IT WAS STATED IN THE REPORT THAT THE CLAVE BROKE. EVENT WAS NOTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARMED. THE TYPE OF BREAK AND THE EFFECT OF THE BREAKAGE WAS NOT STATED. ICU MEDICAL'S SAMPLE INVESTIGATION CLARIFIED THAT THE BREAK BREACHED THE FLUID PATH AND LEAKAGE WOULD BE PROBABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379443 ↗
• MalfunctionFeb 10, 2026Particulates

  AN EMAIL WAS RECEIVED REGARDING A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN STATING THAT A WHITE POWDERY SUBSTANCE WAS OBSERVED STUCK TO THE INNER WALL OF THE TUBE BENEATH THE FILTER VENT DURING PRIMING, AND IT APPEARED TO SLOWLY DISSOLVE AND FALL WHEN ENCOUNTERING LIQUID. NO DRUG WAS INVOLVED IN THE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305115 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING TWO PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN STATING THAT THERE WAS LEAKAGE FROM THE CLAVE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304002 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  AN EVENT INVOLVING A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN REPORTED THAT BLUE CLAVE ABOVE BURETTE LEAKAGE. 5FU WAS INVOLVED IN THE EVENT. THE EVENT WAS NOTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197973 ↗
• MalfunctionJan 14, 2026Material Separation

  THE EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WHERE IT WAS REPORTED THAT THE CLAVE ADDITIVE PORT DISCONNECTED. NO DRUG WAS INVOLVED IN THE EVENT. THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073986 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  THE COMPLAINT/EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WHERE THE CUSTOMER REPORTED A LEAK DURING PATIENT USE. THE CUSTOMER STATED THAT SHORTLY AFTER INITIATING THE INFUSION, THE NURSE RETURNED TO FIND THE 150ML BURETTE INEXPLICABLY FILLED WITH AN UNSPECIFIED FLUID/MEDICATION. IT WAS OBSERVED THAT FLUID WAS LEAKING FROM THE LOWER EDGE OF THE BLUE CLAVE ON THE SECONDARY PORT. WHEN THE CUSTOMER ATTEMPTED TO INSPECT THE DEVICE, THE BLUE CLAVE DETACHED. THERE WAS NO UNPROTECTED DRUG EXPOSURE TO EITHER PATIENT OR HEALTHCARE PROFESSIONAL(S). 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 24012244 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN STATED IN THE REPORTED THAT LEAKAGE NOTED AT DRIP CHAMBER. EVENT WAS NOTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARMED. DURG INFORMATION WAS UNKNOWN. THERE WAS NO UNPROTECTED CHEMO EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824972 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVED A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN REPORTED THAT THE STOP VALVE HAS BEEN CLOSED, BUT THE BAG STILL CONTINUOUSLY DRIPS WATER. EVENT WAS NOTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARMED. DRUG NAME WAS UNKNOWN. THERE WAS NO DRUG EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824962 ↗
• MalfunctionDec 14, 2025Separation Problem; Separation Problem

  AN INCIDENT INVOLVING A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN REPORTED THAT THE CLAVE FELL OFF DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799930 ↗

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-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-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