Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Morph AccessPro Steerable Introducer Recalled by Biocardia, Inc. Due to Firm discovered the potential for particulates in the...
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 Biocardia, Inc. directly.
Affected Products
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
Quantity: ~2541 units - both catalog numbers.
Why Was This Recalled?
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biocardia, Inc.
Biocardia, Inc. 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