PlumRecalls & reported problems across all models

We found 26 models of Plum by ICU Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,358 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2017 and Sep 30, 2026 — classified as 2 deaths, 11 injuries, 1,345 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (875 reports).

6 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Plum recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-3162-2026 · Root cause: Process control · Recall details · FDA record ↗

2. 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 · names 9 of these models · Recall details · FDA record ↗

3. Jul 29, 2019Terminated

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

   Z-0145-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jul 29, 2019Terminated

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

   Z-0128-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

6. Jul 29, 2019Terminated

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

   Z-0126-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Plum problems

Plum models

26 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Plum 1468728

  Set, administration, intravascular
  1 recall2 deaths482 reports
• Plum 1425628

  Set, administration, intravascular
  1 recall204 reports
• Plum 1425528

  Set, administration, intravascular
  1 recall164 reports
• Plum 1427329

  Set, administration, intravascular
  214 reports
• Plum 1233912

  Set, administration, intravascular
  1 recall131 reports
• Plum 1187912

  Pump, infusion
  1 recall8 reports
• Plum 1425128

  Set, administration, intravascular
  1 recall1 report
• Plum 1495388

  Set, administration, intravascular
  1 recall0 reports
• Plum 1973201

  Set, administration, intravascular
  1 recall0 reports
• Plum 1427128

  Set, administration, intravascular
  1 recall0 reports
• Plum 1467928

  Set, administration, intravascular
  1 recall0 reports
• Plum 1495588

  Set, administration, intravascular
  1 recall0 reports
• Plum 2061928

  Set, administration, intravascular
  1 recall0 reports
• Plum 1424328

  Set, administration, intravascular
  1 recall0 reports
• Plum 2400701

  Set, administration, intravascular
  1 recall0 reports
• Plum 1424828

  Set, administration, intravascular
  43 reports
• Plum 1253905

  Set, administration, intravascular
  41 reports
• Plum 1425428

  Set, administration, intravascular
  36 reports
• Plum 1421228

  Set, administration, intravascular
  13 reports
• Plum 1424228

  Set, administration, intravascular
  6 reports
• Plum 2079225

  Pump, infusion
  4 reports
• Plum 1194802

  Set, administration, intravascular
  3 reports
• Plum 1203012

  Set, administration, intravascular
  3 reports
• Plum 1239125

  Pump, infusion
  3 reports
• Plum 1253828

  Set, administration, intravascular
  1 report
• Plum 1955488

  Set, administration, intravascular
  1 report

Recent Plum adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951774 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951595 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937656 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936116 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak; Free or Unrestricted Flow; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934694 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924633 ↗
• MalfunctionSep 28, 2026Environmental Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924374 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923546 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923251 ↗
• MalfunctionSep 25, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903120 ↗
• MalfunctionSep 25, 2026Environmental Particulates

  The event involved a Primary Plum Set reported that there is dirt in the drip chamber. The issue was noted during priming. There were no concomitant drug and concomitant device involved. There was no bleedback, no biohazard, no user facility MedWatch, and no chemo. The device was not reprocessed or resterilized.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897908 ↗
• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888192 ↗
• MalfunctionSep 24, 2026Free or Unrestricted Flow

  The event involved a Primary PLUMSET, PE Lined Tubing, 107 Inch. It was reported that even after pressing the stop button, the medicine keeps flowing and won't stop. This issue led to over delivery during infusion. There was patient involvement but no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883060 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873863 ↗
• MalfunctionSep 23, 2026Break; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873245 ↗

Other ICU Medical, Inc. products

• CADD123 models · 53,012 reports · 21 recalls
• Medfusion16 models · 13,114 reports · 5 recalls
• Bivona469 models · 2,811 reports · 29 recalls
• Level 152 models · 3,733 reports · 1 recall
• Portex409 models · 3,479 reports · 5 recalls
• Cleo6 models · 2,782 reports
• Pneupac23 models · 1,972 reports
• Medex98 models · 774 reports · 23 recalls