Atellica® VTR Syringes 11561344Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00709078013362), received between Aug 22, 2024 and Jul 3, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, BLOOD SPLASHED ONTO A NURSE'S FACE AND ARMS WHILE PUSHING BLOOD INTO A 3CC-50U VENTED & VENTED TIP CAP LS SYRINGE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 04APR2025 REPORTED, THERE WAS NO EVIDENCE OF DAMAGE TO THE SYRINGE; THE BLOOD SPLASH OCCURRED WHEN AN ATTEMPT TO VENT THE SYRINGE WAS PERFORMED. IT WAS ADDITIONALLY REPORTED, THE SYRINGE 'LOOKED NORMAL'. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22398577 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE ISSUE OCCURRED WHERE AFTER REMOVING AIR BUBBLES BLOOD WAS LEAKING THROUGH THE FILTER CAP AND HIT THE PATIENT'S ARM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793061 ↗
• MalfunctionNov 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT SAMPLES. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2028807-2024-00073 FOR THE FIRST REPORT. IT WAS REPORTED, THE SAMPLE CLOTTED IN THE ATELLICA VTR SYRINGE; THERE WAS NO REPORTED INJURY OR DELAY OF RESULTS OR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762200 ↗
• MalfunctionNov 21, 2024Fitting Problem; Fitting Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2028807-2024-00071 FOR THE FIRST REPORT IT WAS REPORTED, POORLY FITTING SYRINGE CAP LEAD TO BLOOD LEAKING AND CONTAMINATION DUE TO FILTER CAP POPPING OFF DURING AIR EXPULSION POST BLOOD COLLECTION. NO ADDITIONAL INFORMATION CONCERNING THE CONTAMINATION WAS PROVIDED; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20754034 ↗
• MalfunctionNov 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, BLOOD SPLATTERED INTO AN OPERATOR'S EYE WHILE EXPELLING AIR FROM AN ATELLICA VTR SYRINGE; THERE WAS NO REPORTED INJURY. ADDITIONALLY, IT WAS NOTED THE PATIENTS BLOOD WAS KNOWN TO CONTAIN BLOOD BORNE PATHOGENS AND TESTING CONTINUES FOR BLOOD BORNE PATHOGENS AND RELEVANT TREATMENT THEREAFTER. THE CURRENT CONDITION OF THE OPERATOR WAS NOT REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 20753887 ↗
• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  BLOOD IS COMING OUT OF THE SYRINGE WHEN REMOVING AIR BUBBLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041059 ↗