Excelsior E0100-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10363807100302), received between Oct 11, 2017 and Aug 18, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Short Fill; Short Fill

  IT WAS REPORTED THAT THE SYRINGE WAS FILLED TO "1 ML INSTEAD OF 2.5 ML".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835768 ↗
• MalfunctionJun 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON 05/23/2025 THEY WERE "PREPARING FOR INJECTION TO PATIENT'S CENTRAL LINE" THE SALINE FLUSH WAS MISSING THE SALINE FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196506 ↗
• InjuryMay 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2025 WHEN REMOVING THE PRODUCT FROM THE PACKAGE THE SYRINGE WAS NOTED "TO CONTAIN ONLY AIR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036221 ↗
• MalfunctionMay 9, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2025 WHEN REMOVING THE SYRINGE FROM THE PACKAGING IT WAS NOTED THAT THERE WAS "ONLY AIR" WITHIN THE SYRINGE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995856 ↗
• MalfunctionApr 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO FLUID IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936300 ↗
• MalfunctionApr 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  3ML PREFILLED SYRINGE WAS "NOTED TO HAVE AIR IN THE SYRINGE AND NO FLUID/SALINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866113 ↗
• MalfunctionOct 11, 2017Device Operates Differently Than Expected

  WHEN USED WITH THE CAREFUSION SYRINGE MODULE AND MICROBORE TUBING, THE PUMP WILL INTERMITTENTLY ALARM AND DISPLAY "OCCLUDED PATIENT SIDE." THE RN WILL THEN FLUSH THE LINE AT THE HUB OR THROUGH THE MICROBORE TUBING OFF OF THE PUMP WITHOUT RESISTANCE OR INCREASE PRESSURE. MANUFACTURER RESPONSE FOR SALINE, VASCULAR ACCESS FLUSH, EXCELSIOR (PER SITE REPORTER): MANUFACTURER IS WORKING WITH OUR BIOMEDICAL DEPARTMENT TO TRY AND REPLICATE THE EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6941448 ↗