Recall Z-1771-2017
Cardiovascular Systems Inc · initiated March 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.
Codes / lots: Lot 156032
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
Customers were sent an Urgent Medical Device Recall letter beginning March 03, 2017. The letter identified affected product, reason for recall, and asked for affected devices to be removed from use and return to CSI. Questions can be directed to CSI Customer Service at 877-274-0901, or your CSI Sales Representative.
Details
- Recall number
- Z-1771-2017
- Initiated
- March 3, 2017
- Terminated
- November 28, 2017
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- 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
- Recalling firm
- Cardiovascular Systems Inc, Saint Paul, MN