TheraSphere Administration Set recalled for potential leaks at catheter connection
Boston Scientific is recalling TheraSphere Administration Sets due to potential for leaks and loosening at the patient catheter connection. The recall affects 4980 sets distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a risk-of-harm product where no illnesses or injuries have been reported. The hazard is theoretical (potential for leaks and loosening), so per the rubric, the maximum severity score is 3.
Plain-English summary
Boston Scientific Corporation is recalling the TheraSphere Administration Set (model REF OTT-SPE-FP-226, GTIN 05060116920253) due to a potential for leaks and loosening at the patient catheter connection. This defect could affect the integrity and functionality of the administration set during clinical use.
The recall involves 4980 sets distributed worldwide to the United States and 19 other countries, including Belgium, Canada, Germany, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina. Affected lot numbers are 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, and 692E.
Healthcare providers and facilities using these administration sets should verify the lot numbers of their inventory against the affected lot list. Organizations in possession of affected units should contact Boston Scientific Corporation for instructions regarding product return or replacement.
The recalled product
- Product
- TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-leak
- connection-loosening
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- GTIN 05060116920253
- Lot Numbers: 001E
- 002E
- 004E
- 005E
- 006E
- 007E
- 114E
- 690E
- 692E
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27