TheraSphere Administration Set may leak or loosen at catheter connection
Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were 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 recall receives a High severity rating because it involves a risk-of-harm product with potential for patient harm through leaks or loosening at a critical catheter connection, but no injuries or deaths have been reported. As a Class II (not Class I) recall with no reported incidents, it does not meet the criteria for Severe or Critical classification.
Plain-English summary
Boston Scientific Corporation is recalling the TheraSphere Administration Set (REF OTT-SPE-FP-001) due to the potential for leaks and loosening at the patient catheter connection. This device is used in radiotherapy administration.
The recall affects approximately 4,200 sets distributed worldwide, including throughout the United States and to Belgium, Canada, Germany, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina. The affected lot numbers include 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, and 61732176.
This is classified as a Class II recall by the U.S. Food and Drug Administration.
The recalled product
- Product
- TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,200
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 05060116920635
- Lot Numbers: 61673698
- 61673699
- 61673700
- 61673702
- 61694124
- 61705932
- 61706656
- 61705933
- 61732176
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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