Z-1095-2014Class III

CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125

Name: Z-1095-2014 CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125
Creator: Cardiovascular Systems, Inc.
Published: 2014-01-27
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2014-01-27 / Terminated / root cause: manufacturing process

FDA source

Cardiovascular Systems, Inc. began a recall of CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate... on 2014-01-27. FDA classified it as Class III and gives the reason as "Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1095-2014
Classification: Class III
Status: Terminated
Initiated: 2014-01-27
Posted: 2014-02-26
Terminated: 2014-05-05
Recalling firm: Cardiovascular Systems Incorporated
Product: CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Product code: MCX Catheter, Coronary, Atherectomy
Reason for recall: Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cardiovascular Systems Inc. sent an "Urgent Medical Device Recall" letter dated January 27, 2014 to all affected customers. The letter described the affected product, recall description and actions to be taken. Customers were instructed to complete and return the attached Customer Acknowledgement Form and return the device i available. For further information they should contact CSI Customer Service at 651 Campus Drive, Saint Paul, MN 55112, Tele 877-274-0901, Fax 612-677-3355.
Quantity in commerce: 318
Distribution: USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
Product codes and lots: Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1095-2014	Class III	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25

Product code MCX

K071073Class IISolar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies / cleared 2007-05-11

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)