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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific Corporation: Potential for leaks and loosening at the patient catheter connection

Agency Publication Date: August 19, 2021
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Affected Products

Product: TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E

Lot Numbers:
Numbers
Product: TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88369
Status: Active
Manufacturer: Boston Scientific Corporation
Manufactured In: United States
Units Affected: 2 products (4980 sets; 4200 sets)
Agency Last Updated: August 23, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.