Boston Scientific TheraSphere Set Recall: Leaks at Catheter Connection Risk
Boston Scientific recalls TheraSphere Administration Set model 990226.SPE due to potential leaks and loosening at patient catheter connection. Affected units include specific lot numbers and GTIN.
Use caution until it’s fixed
Potential for leaks and loosening at the patient catheter connection
Contact the company
What happened, in plain English
Boston Scientific is recalling TheraSphere Administration Sets with model number 990226.SPE because they may leak or loosen at the patient catheter connection. This could lead to complications during medical procedures if not fixed. Read more at govinfonow.com/recall/62162-boston-scientific-therasphere-set-recall-leaks-at-catheter-connection-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62162-boston-scientific-therasphere-set-recall-leaks-at-catheter-connection-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2327-2021
Cite this page
“Boston Scientific TheraSphere Set Recall: Leaks at Catheter Connection Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62162-boston-scientific-therasphere-set-recall-leaks-at-catheter-connection-risk. Based on FDA recall #Z-2327-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2327-2021%22&limit=1).
Why it’s dangerous
The device may leak or loosen at the patient catheter connection during use, which could cause improper delivery of radiation therapy or other medical complications. This risk is specific to the connection point where the device interfaces with the patient's body.
Who’s affected
Patients using this medical device for procedures like radiation therapy are most at risk. Healthcare providers who handle the device during treatments may also be affected.
How to tell if you have this one
Check for the model number 990226.SPE on the device. Affected units include specific lot numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E. The GTIN is 05060116920253.
- Brand
Boston Scientific- Product
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2327-2021 | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE); GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E | 4980 sets |
| Z-2328-2021 | TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE); GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176 | 4200 sets |
What to do — step by step
Check Device Model
Look for the model number 990226.SPE on the TheraSphere Administration Set.
Contact Manufacturer
Reach out to Boston Scientific Corporation for further instructions on handling the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2327-2021 (July 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2327-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.