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 Tyvek packaging may be worn, causing loss of...
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: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
Quantity: 11 units
Why Was This Recalled?
Tyvek packaging may be worn, causing loss of package integrity.
Where Was This Sold?
This product was distributed to 6 states: FL, KS, MA, MI, OH, WY
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