Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Boston Scientific Recalled by Boston Scientific Corporation Due to The sterile pouch of the devices from this...
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 Boston Scientific Corporation directly.
Affected Products
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Quantity: 7
Why Was This Recalled?
The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
Where Was This Sold?
This product was distributed to 1 state: TX
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report