Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Distal Access Catheter: Model Numbers: 90121 Recalled by Concentric Medical Inc Due to Distal Access Catheters were shipped to US customers...
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 Concentric Medical Inc directly.
Affected Products
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Quantity: 87 units
Why Was This Recalled?
Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
Where Was This Sold?
This product was distributed to 17 states: AL, AZ, CA, FL, IL, KY, MA, MI, MS, NY, NC, OK, PA, TN, TX, VA, WA
About Concentric Medical Inc
Concentric Medical Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report