MEDRAD® Mark 7 Arterion Injection System (REF ART 700 PEDL, ART 700 TABL, ART 700 OCS, ART 700 BASC, ART 700 VFL)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00616258009360), received between May 7, 2020 and Mar 12, 2025 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT 65-YEAR-OLD MALE HAD EXPERIENCED LEFT-SIDED WEAKNESS AND A DROP IN OXYGEN SATURATION LEVELS DURING A LEFT HEART CATHETERIZATION WHILE CONNECTED TO A MEDRAD® MARK 7 ARTERION INJECTION SYSTEM (SN (B)(6)). MEDICAL STAFF SUSPECTED AN ALLEGED AIR INJECTION OCCURRED WHILE THE INJECTOR WAS CONNECTED TO THE PATIENT; HOWEVER, THIS WAS NOT CONFIRMED ON THE FLUOROSCOPIC IMAGES FROM THE PROCEDURE. FOLLOWING THE DEVELOPMENT OF THE REPORTED SYMPTOMS, A STROKE CODE WAS CALLED, THE PATIENT WAS GIVEN MEDICATION, A TEMPORARY PACEMAKER, AND WAS TAKEN TO THE RADIOLOGY DEPARTMENT WHERE A CT OF THE HEAD WAS PERFORMED, AND AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE AMOUNT OF AIR WAS NOT QUANTIFIED. THE PATIENT IS IN THE ICU AND IS REPORTED AS BEING STABLE.

  Patient problems: Air Embolism; Low Oxygen Saturation; Stroke/CVA

  MAUDE report 21584442 ↗
• InjuryMay 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THE FOLLOWING: A PATIENT WAS UNDERGOING A TAVR PROCEDURE AND SUFFERED AN AIR INJECTION WHILE CONNECTED TO THE ARTERION INJECTOR SYSTEM. THE AMOUNT OF AIR IS UNKNOWN. THE PATIENT WAS REPORTED TO EXPERIENCE CHANGES TO THEIR EKG, BLOOD PRESSURE, AND OXYGEN SATURATION. NO FURTHER DETAILS HAVE BEEN PROVIDED BY THE CUSTOMER SITE FOLLOWING MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Air Embolism

  MAUDE report 10032471 ↗

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