MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube ART 700 SYR (UDI 00616258005546)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258005546), received between Oct 12, 2017 and Oct 12, 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.

• MalfunctionOct 12, 2017Device Contamination with Chemical or Other Material

  THE SITE REPORTED THE FOLLOWING: AFTER OPENING THE ARTERION DISPOSABLE KIT AND UPON FILLING OF THE SYRINGE, THEY SAW A HAIR OR HAIR-LIKE STRAND OF UNKNOWN ETIOLOGY WITHIN THE FLUID. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945570 ↗

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