Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TheraSphere Administration Set Recalled by Boston Scientific Corporation Due to Potential for leaks and loosening at the patient...
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
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Quantity: 4200 sets
Why Was This Recalled?
Potential for leaks and loosening at the patient catheter connection
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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