FDAClass IIApril 19, 2017

ViperWire Advance Peripheral Guide Wire with Flex Tip recall

ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless…

Why was ViperWire Advance Peripheral Guide Wire with Flex Tip recalled?

Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flextip.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 156032

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…
Recalling firm
Cardiovascular Systems Inc
Quantity
186 devices
Distribution
Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA
Recall date
April 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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