| Class 2 Device Recall ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire | |
Date Initiated by Firm | February 09, 2017 |
Date Posted | April 10, 2017 |
Recall Status1 |
Terminated 3 on July 27, 2017 |
Recall Number | Z-1877-2017 |
Recall Event ID |
76928 |
510(K)Number | K151260 |
Product Classification |
Catheter, peripheral, atherectomy - Product Code MCW
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Product | 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 acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. |
Code Information |
Lot #: 175069, 175070, 176255 |
Recalling Firm/ Manufacturer |
Cardiovascular Systems Inc 1225 Old Highway 8 NW Saint Paul MN 55112-6416
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Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 in Commerce | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MCW
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