Atellica® VTR Syringes 11561341Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00709078013300), received between Nov 21, 2024 and Nov 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 FIRST OF TWO REPORTS. REFER TO 2028807-2024-00074 FOR THE SECOND 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 20762261 ↗
• 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 FIRST OF TWO REPORTS. REFER TO 2028807-2024-00072 FOR THE SECOND 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 20753819 ↗