Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Sizing Error
Cardiovascular Systems Inc. is recalling one lot of ViperWire Advance Peripheral Guide Wires because they may contain the wrong size product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Cardiovascular Systems Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18. The recall involves 186 devices that were distributed nationwide in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS, NC, NM, RI, TX, and VA.
The recall is being conducted because the recalled lot may contain a 0.014-inch ViperWire Advance Flextip product instead of the intended 0.018-inch ViperWire Advance with Flextip. The guide wire is a smooth, stainless steel wire with a silicone coating and a radiopaque distal spring tip, used for proper positioning of device crowns within peripheral arteries.
The affected lot number is 156032. The devices were sterilized with Ethylene Oxide. The guide wire torquer, a small plastic accessory packaged with the guide wire, provides a gripping surface for manipulating the guide wire.
The recalled product
- Product
- ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the
- Manufacturer
- Cardiovascular Systems Inc
- Hazard
- Affected units
- 186
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)
- Lot 156032
Distribution
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