Injector, Contrast Medium, Automatic
FDA adverse event reports and recall history for injector, contrast medium, automatic (product code IZQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 575
- Deaths
- 17
- Injuries
- 247
- Malfunctions
- 256
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2012-01-20TerminatedPackaging
Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures.
Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101.
- 2011-07-21TerminatedOther
Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.
- 2008-08-15TerminatedComponent design/selection
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.
Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.
Monitor injector, contrast medium, automatic automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.