ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Pro
FDA device recall Z-1877-2017 · posted 2017-04-10 · Terminated
Recall details
- Recalling firm
- Cardiovascular Systems Inc
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 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
- Date initiated
- 2017-02-09
- Date posted
- 2017-04-10
- Date terminated
- 2017-07-27
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD (K151260) | Cardiovascular System, Inc. | 2015-06-10 |