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.
Recall
- Recall Number
- Z-1095-2014
- Event Number
- 67445
- Firm
- Cardiovascular Systems, Inc.
- FEI Number
- 3004742232
- Product Code
- MCX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 27, 2014
- Posted
- February 26, 2014
- Terminated
- May 5, 2014
- Address
- 651 Campus Dr, Saint Paul, MN, 55112-3495
Description
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.
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
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.
USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
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