Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufact
FDA device recall Z-1250-2009 · posted 2009-04-17 · Terminated
Recall details
- Recalling firm
- Cardiovascular Systems, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 10 devices
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-03-16
- Date posted
- 2009-04-17
- Date terminated
- 2012-04-20
- Location
- Arden Hills, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K071427) | Cardiovascular Systems, Inc. | 2007-08-30 |