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Open, Classified

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

FDA Recall Z-2328-2021 · Posted 2021-08-19

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeNAW
Date Initiated2021-07-23
Product Quantity4200 sets

Reason for Recall

Potential for leaks and loosening at the patient catheter connection

Firm Action

The firm disseminated a Medical Device Product Advisory on 07/23/2021 by overnight mail delivery. The letter explained the issue and directed users to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during ThersSphere administration.

Root Cause

Component change control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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