VersaCross RF wire lots may have a punctured sterile barrier pouch
The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: a compromised sterile barrier on a device used inside the heart, with no infection reported in the source.
Plain-English summary
The VersaCross RF Wire (VXW), product ID VXW0002, UDI-DI 00685447006121, indicated for creation of an atrial septal defect in the heart, is being recalled. The action covers 14,724 units and lot 35935598. The source notes this device is approved and commercialised in Japan only.
According to the manufacturer, there is a potential for a hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. The manufacturer states the issue could potentially lead to systemic infection and sepsis in a worst case scenario, and that potential punctures may go undetected in clinical settings due to their small size and variable location. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States and to Canada and Hong Kong among other markets.
Facilities should identify affected stock using the product ID, UDI-DI and lot number above and follow the instructions issued by the manufacturer.
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
- Affected units
- 14,724
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.
Part of a larger recall action
This product is one of 4 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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