Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is Recalled by Acist Medical Systems Due to ACIST Medical Systems is issuing a voluntary recall...
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 Acist Medical Systems directly.
Affected Products
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Quantity: 6640 units
Why Was This Recalled?
ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Acist Medical Systems
Acist Medical Systems has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report