Cardiac device recall due to potential sterile barrier compromise
Boston Scientific is recalling the VersaCross RF Wire cardiac device due to potential holes in the sterile barrier pouch. These defects could compromise device sterility and potentially lead to systemic infection or sepsis.
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 device with a critical potential consequence (systemic infection or sepsis) from sterile barrier compromise. While the hazard is not yet clinically manifested, the serious nature of potential complications in a life-critical cardiac device justifies a High severity rating per the FDA rubric.
Plain-English summary
Boston Scientific Corporation is recalling the VersaCross RF Wire (VXW), a cardiac device indicated for creation of an atrial septal defect, due to a potential defect in the sterile barrier.
The recalled devices have a potential for holes in the Tyvek layer of the sterile barrier pouch that may compromise device sterility. Small punctures may go undetected during clinical inspection due to their small size and variable location. Compromised sterility could potentially lead to systemic infection and sepsis.
The recall affects approximately 14,724 units distributed worldwide, including the United States, Canada, Hong Kong, and Japan. The affected lot is UDI-DI 00685447006121 Lot 35935598.
Patients and healthcare providers should contact Boston Scientific Corporation for information about this recall and guidance regarding affected devices.
The recalled product
- Product
- VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Device
- Hazard
- sterile-barrier-compromise
- infection-risk
- sepsis
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 (1)
- UDI-DI 00685447006121 Lot 35935598
Distribution
Distributed nationwide across the United States.
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