Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.
FDA Recall Z-2028-2009 · Posted 2009-09-10
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Recalling FirmCardiovascular Systems, Inc.
Recall StatusTerminated
Product CodeMCW
Date Initiated2009-04-16
Date Terminated2011-12-10
Product Quantity8
Reason for Recall
CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s
Firm Action
Cardiovascular System, Inc. issued an "URGENT: Medical Device Correction" letter dated April 16, 2009. The letter described the product and the problem. The letter informed the consignees that the "Device" re-labeling would be performed by company representatives. Devices will not be returned.
For further information, contact Cardiovascular System, Inc. 1-877-274-0901.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Nationwide Distribution -- CA, GA, MI, NY, NY and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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