Boston Scientific Corporation TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
Products Sold
GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
Boston Scientific Corporation is recalling TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) due to Potential for leaks and loosening at the patient catheter connection. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for leaks and loosening at the patient catheter connection
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026