Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff Recalled by Boston Scientific Corporation Due to Mislabled: AMS 800 occlusive cuff labeled as 4.5...
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
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Quantity: 1 unit
Why Was This Recalled?
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Where Was This Sold?
This product was distributed to 1 state: MN
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