TheraSphere Administration Set recallZ-2328-2021 · Boston Scientific Corporation · initiated Jul 23, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for leaks and loosening at the patient catheter connection
FDA root cause category: Component change control
What the company is doing
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.
Recall details
- Recall number
- Z-2328-2021
- Status
- Open, Classified
- Initiated by the company
- Jul 23, 2021
- Posted by the FDA
- Aug 19, 2021
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 4200 sets
- Product code
- NAW
- FDA submissions
- P200029
- Distribution
- 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.
Product description
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Code information (models, lots, serial numbers)
GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TheraSphere Administration Set OTT-SPE-FP-001Biocompatibles Uk Ltd · Microspheres Radionuclide2 recalls2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 88369).
- Z-2327-2021 · Open, ClassifiedTheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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