Z-2028-2009

Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration...

Name: Z-2028-2009 Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration...
Creator: Cardiovascular Systems, Inc.
Published: 2009-04-16
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2009-04-16 / Terminated / root cause: labeling and UDI

FDA source

Cardiovascular Systems, Inc. began a recall of Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide... on 2009-04-16. The reason FDA records is "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...". 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-2028-2009
Status: Terminated
Initiated: 2009-04-16
Posted: 2009-09-10
Terminated: 2011-12-10
Recalling firm: Cardiovascular Systems Incorporated
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.
Product code: MCW Catheter, Peripheral, Atherectomy
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
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
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.
Quantity in commerce: 8
Distribution: Nationwide Distribution -- CA, GA, MI, NY, NY and TN.
Product codes and lots: Lot Number: 23181.

Product code MCW

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)