Atellica® VTR Syringes 11561340Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00709078013287), received between Apr 20, 2023 and Apr 20, 2023 — classified as 3 malfunctions.

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

• MalfunctionApr 20, 2023Contamination; Contamination

  THE CUSTOMER HAS NOTED MULTIPLE ISSUES WITH THE SYRINGES: 1. THE SYRINGE DOESN'T ALWAYS FILL PROPERLY 2. WHEN ASPIRATING, AIR GETS INTO THE SAMPLE (ALTHOUGH THEY DID STATE THAT THIS OFTEN HAPPENS WITH SELF-FILLING SYRINGES). 3. BLOOD ALSO COMES THROUGH THE CAP (BLOOD DRIPPED THROUGH THE CAP). 4. BLOOD HAS SOMETIMES ALSO FLOWED THROUGH THE PLUNGER OF THE SYRINGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16779818 ↗
• MalfunctionApr 20, 2023Contamination; Contamination

  THE CUSTOMER HAS NOTED MULTIPLE ISSUES WITH THE SYRINGES: THE SYRINGE DOESN'T ALWAYS FILL PROPERLY. WHEN ASPIRATING, AIR GETS INTO THE SAMPLE (ALTHOUGH THEY DID STATE THAT THIS OFTEN HAPPENS WITH SELF-FILLING SYRINGES). BLOOD ALSO COMES THROUGH THE CAP (BLOOD DRIPPED THROUGH THE CAP). BLOOD HAS SOMETIMES ALSO FLOWED THROUGH THE PLUNGER OF THE SYRINGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16779154 ↗
• MalfunctionApr 20, 2023Contamination; Contamination

  THE CUSTOMER HAS NOTED MULTIPLE ISSUES WITH THE SYRINGES: 1. THE SYRINGE DOESN'T ALWAYS FILL PROPERLY. 2. WHEN ASPIRATING, AIR GETS INTO THE SAMPLE (ALTHOUGH THEY DID STATE THAT THIS OFTEN HAPPENS WITH SELF-FILLING SYRINGES). 3. BLOOD ALSO COMES THROUGH THE CAP (BLOOD DRIPPED THROUGH THE CAP). 4. BLOOD HAS SOMETIMES ALSO FLOWED THROUGH THE PLUNGER OF THE SYRINGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16779145 ↗