MaxPlusRecalls & reported problems across all models

We found 18 models of MaxPlus by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 762 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2018 and Sep 28, 2026 — classified as 7 injuries, 755 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (185 reports).

2 FDA recall records name at least one of these models by its device identifier, 1 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

MaxPlus 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. Jun 16, 2026Open, Classified

   Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.

   Z-2941-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. May 2, 2019Terminated

   After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.

   Z-0049-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported MaxPlus problems

MaxPlus models

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

• MaxPlus MP1000-C

  Set, administration, intravascular
  1 recall265 reports
• MaxPlus MP5303-C

  Set, administration, intravascular
  167 reports
• MaxPlus MP5301-C

  Set, administration, intravascular
  127 reports
• MaxPlus MPX5300-C

  Set, administration, intravascular
  1 recall33 reports
• MaxPlus MPX5305-C

  Set, administration, intravascular
  1 recall2 reports
• MaxPlus MP1000

  Set, administration, intravascular
  43 reports
• MaxPlus MP5314-C

  Set, administration, intravascular
  26 reports
• MaxPlus MP5313-C

  Set, administration, intravascular
  25 reports
• MaxPlus MPX5302-C

  Set, administration, intravascular
  24 reports
• MaxPlus MP5310-C

  Set, administration, intravascular
  11 reports
• MaxPlus MP5312-C

  Set, administration, intravascular
  9 reports
• MaxPlus MPX5301-C

  Set, administration, intravascular
  9 reports
• MaxPlus MP5305-C

  Set, administration, intravascular
  5 reports
• MaxPlus MPX5304-C

  Set, administration, intravascular
  5 reports
• MaxPlus MP5302-C

  Set, administration, intravascular
  3 reports
• MaxPlus MP5304-C

  Set, administration, intravascular
  3 reports
• MaxPlus MPX9103

  Set, administration, intravascular
  3 reports
• MaxPlus MPX9108-C

  Set, administration, intravascular
  2 reports

Recent MaxPlus adverse event reports

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

• MalfunctionSep 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921291 ↗
• MalfunctionSep 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918132 ↗
• MalfunctionSep 25, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906082 ↗
• MalfunctionSep 25, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906081 ↗
• MalfunctionSep 25, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906080 ↗
• MalfunctionSep 25, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906079 ↗
• MalfunctionSep 22, 2026Crack; Leak/Splash

  It was reported, MaxPlus, crack, causing leak.The following was provided by the initial reporter: A crack formed at the connection between the needle-free connector and the infusion set during an IV infusion, causing fluid leakage.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854718 ↗
• MalfunctionSep 17, 2026Leak/Splash

  It was reported, Maxplus, leak during use.The following was provided by the initial reporter: During use, fluid leakage was discovered at the connection point of the central venous catheter; 10 units were found to be defective.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802835 ↗
• MalfunctionAug 17, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280932 ↗
• MalfunctionAug 17, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280896 ↗
• MalfunctionAug 17, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280895 ↗
• MalfunctionJun 7, 2026Leak/Splash

  IT IS REPORTED, MAXPLUS, LEAK.

  Patient problems: Insufficient Information

  MAUDE report 25422432 ↗
• MalfunctionMay 28, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIMARY IV TUBING BECAME DISCONNECTED FROM IV EXTENSION SET AND IV FLUID LEAKED ALL OVER THE STRETCHER AND ONTO THE PATIENT GOWN AND BEDDING. THIS IS THE SECOND TIME I HAVE SEEN THIS HAPPEN WITH THIS TYPE OF IV EXTENSION SET WHERE THE PRIMARY IV BECOMES ACCIDENTALLY DISCONNECTED. PRODUCT NAME AND/OR CATALOG NUMBER: BD MAX PLUS PRESSURE. LOT NUMBER OR SERIAL NUMBER: N/A ANY INJURIES AND/OR HARM? NO IV EXTENSION SET IS AS FOLLOWS: BD MAX PLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320001 ↗
• MalfunctionMay 28, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIMARY IV TUBING BECAME DISCONNECTED FROM IV EXTENSION SET AND IV FLUID LEAKED ALL OVER THE STRETCHER AND ONTO THE PATIENT GOWN AND BEDDING. THIS IS THE SECOND TIME I HAVE SEEN THIS HAPPEN WITH THIS TYPE OF IV EXTENSION SET WHERE THE PRIMARY IV BECOMES ACCIDENTALLY DISCONNECTED. PRODUCT NAME AND/OR CATALOG NUMBER: BD MAX PLUS PRESSURE LOT NUMBER OR SERIAL NUMBER: N/A ANY INJURIES AND/OR HARM? NO IV EXTENSION SET IS AS FOLLOWS: BD MAX PLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE CLEAR NEEDLELESS CONNECTOR. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319997 ↗
• MalfunctionMay 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE CONNECTOR/STOPPER BECAME DETACHED DURING AGITATION OF SALINE OR CONTRAST DURING ECHO CARDIOGRAM WHICH CAUSED SALINE AND PATIENT BLOOD TO SPRAY ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247337 ↗

Other BD Switzerland Sàrl products

• Alaris, SmartSite160 models · 10,227 reports · 8 recalls
• Alaris85 models · 2,797 reports · 10 recalls
• MaxZero47 models · 2,377 reports
• MaxGuard49 models · 780 reports · 11 recalls
• BD PhaSeal23 models · 992 reports · 2 recalls
• BD SmartSite29 models · 568 reports · 4 recalls
• Alaris, SmartSite, Texium12 models · 291 reports · 5 recalls
• BD PhaSeal Optima11 models · 474 reports · 1 recall