Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Boston Scientific Imager II Angiographic Catheter Recalled by Boston Scientific Corporation Due to A field report indicated some units within 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 Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
Quantity: 39 boxes of 5 (195 units)
Why Was This Recalled?
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
Where Was This Sold?
This product was distributed to 9 states: CA, FL, KY, MO, NM, OK, OR, PA, 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