Recall Z-1877-2017 ยท MCW Catheter, Peripheral, Atherectomy
Cardiovascular Systems Inc
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptabl
| Date | Apr 10, 2017 (initiated Feb 9, 2017) |
| Status | Terminated |
| Reason | CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip. |
| Root cause | Process control |
| Action | On 2/9/2017, consignees were sent a CSI "Urgent Medical Device Recall" letter dated 09 February 2017. The letter described the Affected Product, Recall Description, & Instructions. Advised consignees to immediately remove, return the product & complete the Customer Acknowledgement Form. For further information contact Customer Service, Cardiovascular Systems, Inc., 1225 Old Highway 8 NW Saint Paul, MN 55112 877-274-0901 - Tel, 612-677-3355 - Fax. |
| Quantity | 595 |
| Distribution | US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD Cardiovascular System, Inc., Jun 10, 2015 |