Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Angiographic Injector. Medrad Mark 7 Arterion Injection System Recalled by Bayer Healthcare Due to Software Version SW 005.006_SH, resulted in the removal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bayer Healthcare directly.
Affected Products
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Quantity: 71
Why Was This Recalled?
Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bayer Healthcare
Bayer Healthcare has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report