Recall Z-1877-2017
Cardiovascular Systems Inc · initiated February 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot #: 175069, 175070, 176255
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: Process control
Action taken
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.
Details
- Recall number
- Z-1877-2017
- Initiated
- February 9, 2017
- Posted by FDA
- April 10, 2017
- Terminated
- July 27, 2017
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- 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
- Recalling firm
- Cardiovascular Systems Inc, Saint Paul, MN