Atellica® VTR Syringes 11561350Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10889483479483), received between Nov 14, 2024 and Mar 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (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.

• MalfunctionMar 7, 2025Failure to Seal; Failure to Seal

  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 2028807-2025-00002 FOR THE FIRST REPORT. REFER TO 2028807-2025-00003 FOR THE SECOND REPORT. IT WAS REPORTED, THE SYRINGES WERE UNABLE TO ADEQUATELY RETAIN ARTERIAL BLOOD, DUE TO POOR SEALING OF THE PLUNGER WHICH RESULTED IN: BLOOD LOSS THROUGH THE PLUNGER; THE EFFICIENCY OF COLLECTIONS; DIFFICULTY IN CARRYING OUT ARTERIAL BLOOD SAMPLING, BLOOD LEAKING ONTO SURFACES AND INTO THE ENVIRONMENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551976 ↗
• MalfunctionMar 7, 2025Failure to Seal; Failure to Seal

  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 2028807-2025-00003 FOR THE SECOND REPORT, REFER TO 2028807-2025-00004 FOR THE THIRD REPORT. IT WAS REPORTED, THE SYRINGES WERE UNABLE TO ADEQUATELY RETAIN ARTERIAL BLOOD, DUE TO POOR SEALING OF THE PLUNGER WHICH RESULTED IN: BLOOD LOSS THROUGH THE PLUNGER; THE EFFICIENCY OF COLLECTIONS; DIFFICULTY IN CARRYING OUT ARTERIAL BLOOD SAMPLING, BLOOD LEAKING ONTO SURFACES AND INTO THE ENVIRONMENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551955 ↗
• MalfunctionMar 7, 2025Failure to Seal; Failure to Seal

  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 2028807-2025-00002 FOR THE FIRST REPORT, REFER TO 2028807-2025-00004 FOR THE THIRD REPORT. IT WAS REPORTED, THE SYRINGES WERE UNABLE TO ADEQUATELY RETAIN ARTERIAL BLOOD, DUE TO POOR SEALING OF THE PLUNGER WHICH RESULTED IN: BLOOD LOSS THROUGH THE PLUNGER; THE EFFICIENCY OF COLLECTIONS; DIFFICULTY IN CARRYING OUT ARTERIAL BLOOD SAMPLING, BLOOD LEAKING ONTO SURFACES AND INTO THE ENVIRONMENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551954 ↗
• MalfunctionNov 14, 2024Fail-Safe Problem; Protective Measures Problem; Fail-Safe Problem; Protective Measures Problem

  SUNMED HOLDINGS LLC., RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPERATE UNITS, INVOLVING THE SAME NURSE. THIS IS THE FIRST REPORT OF TWO REPORTS. REFER TO 2028807-2024-00052. IT WAS REPORTED A FAULT IN THE NEEDLE'S ANTI-PRICKING SAFETY SYSTEM. ALTHOUGH THE ANTI-PRICKING SYSTEM WAS ACTIVATED, THE TIP OF THE NEEDLE REMAINED EXPOSED, RESULTING IN THE ACCIDENTAL PRICKING OF A NURSE, NO PATENT WAS INVOLVED OR IMPACTED.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20690001 ↗