Z-1250-2009

Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene...

Name: Z-1250-2009 Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene...
Creator: Cardiovascular Systems, Inc.
Published: 2009-03-16
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2009-03-16 / Terminated / root cause: labeling and UDI

FDA source

Cardiovascular Systems, Inc. began a recall of Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc... on 2009-03-16. The reason FDA records is "CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1250-2009
Status: Terminated
Initiated: 2009-03-16
Posted: 2009-04-17
Terminated: 2012-04-20
Recalling firm: Cardiovascular Systems Incorporated
Product: Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Customer letters were FedEx'd to CSI Sales Professionals on 03/16/2009, who delivered the letters and helped coordinate the removals of affected product. The letter identified the product, provided a description of the issue and provided instructions to immediately remove from use and return the affected guidewires to CSI. A Customer Acknowledgement Form was asked to be completed and returned with the devices.
Quantity in commerce: 10 devices
Distribution: Nationwide Distribution
Product codes and lots: Lot: P1406641

Product code MCW

K071427Class IIDiamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems, Inc. / cleared 2007-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)