Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Recalled by Oscor, Inc. Due to Complaint that during insertion of the dilator through...
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 Oscor, Inc. directly.
Affected Products
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Quantity: 8
Why Was This Recalled?
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Where Was This Sold?
This product was distributed to 7 states: CA, FL, MD, MO, NJ, NC, TX
About Oscor, Inc.
Oscor, Inc. has 35 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report