Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amplatzer Steerable Delivery Sheath Recalled by Abbott Due to Instructions for use were updated.
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 Abbott directly.
Affected Products
Amplatzer Steerable Delivery Sheath
Quantity: 529 units
Why Was This Recalled?
Instructions for use were updated.
Where Was This Sold?
OUS distribution only
About Abbott
Abbott has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report