Atellica® VTR Syringes 11561345Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00709078013386), received between Aug 14, 2024 and Dec 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Component Missing; Component Missing

  IT WAS REPORTED, BLOOD LEAKED WHILE EXPRESSING AIR, AND SPLASHED OUT FROM THE TOP OF THE CAP ONTO THE OPERATOR'S FACE. IT WAS ADDITIONALLY REPORTED, THE OPERATOR WAS WEARING GLOVES AND GOGGLES AND FOLLOWED THE HOSPITAL GUIDELINES FOR BLOOD EXPOSURE. WHILE INVESTIGATING THE EVENT, IT WAS FOUND THAT THE AFFECTED SYRINGE WAS MISSING THE WHITE FILTER OF THE TIP CAP. THERE WAS NO REPORT OF A DELAY IN THERAPY, HURT, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23844120 ↗
• MalfunctionAug 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2028807-2024-00024 FOR THE FIRST REPORT. REFER TO 2028807-2024-00025 FOR THE SECOND REPORT. IT WAS REPORTED, DURING AIR EXPULSION FOLLOWING BLOOD GAS AND WITH THE SYRINGE CAP IN PLACE, BLOOD LEAKED THROUGH THE CAP. IT WAS ADDITIONALLY NOTED, THE CAP REMAINED ON THE SYRINGE TIP. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981293 ↗
• MalfunctionAug 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2024-00025 FOR THE SECOND REPORT. REFER TO 2028807-2024-00026 FOR THE THIRD REPORT. IT WAS REPORTED, DURING AIR EXPULSION FOLLOWING BLOOD GAS AND WITH THE SYRINGE CAP IN PLACE, BLOOD LEAKED THROUGH THE CAP. IT WAS ADDITIONALLY NOTED, THE CAP REMAINED ON THE SYRINGE TIP. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981292 ↗
• MalfunctionAug 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2028807-2024-00024 FOR THE FIRST REPORT. REFER TO 2028807-2024-00026 FOR THE THIRD REPORT. IT WAS REPORTED, DURING AIR EXPULSION FOLLOWING BLOOD GAS AND WITH THE SYRINGE CAP IN PLACE, BLOOD LEAKED THROUGH THE CAP. IT WAS ADDITIONALLY NOTED, THE CAP REMAINED ON THE SYRINGE TIP. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981273 ↗