MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube ART 700 SYR (UDI 00616258007847)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258007847), received between Dec 14, 2017 and Dec 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

1 other recall cover devices cleared under the same FDA submission (K112086); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING SEVERAL ARTERION DISPOSABLE SYRINGE KITS AND UPON INSPECTION, THEY NOTICED THE PRESENCE OF FINE WHITE PARTICLES AROUND THE SYRINGES AS WELL AS THE QUICK FILL TUBES (QFT). THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KITS. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7117715 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112086. One submission often covers many models, so check the product and lot details in each record.

• Z-0745-2019 · Dec 14, 2018 · Terminated
  MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Inje