Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RenovoCath RC 120 Recalled by RenovoRx, Inc. Due to Incorrect version of Instructions for Use were shipped...
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 RenovoRx, Inc. directly.
Affected Products
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
Quantity: 11 units
Why Was This Recalled?
Incorrect version of Instructions for Use were shipped to two US customers.
Where Was This Sold?
This product was distributed to 2 states: CA, FL
About RenovoRx, Inc.
RenovoRx, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report