Cardiovascular Systems, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Cardiovascular Systems, Inc.
Lot Codes / Batch Numbers
Lot Number: 23181.
Products Sold
Lot Number: 23181.
Cardiovascular Systems, Inc. is recalling Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Ex due to 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 sh. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026