Recall Z-1095-2014 ยท MCX Catheter, Coronary, Atherectomy
Cardiovascular Systems, Inc.
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.
| Date | Feb 26, 2014 (initiated Jan 27, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 318 |
| Distribution | USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE Ge Medical Systems Information Technologies, May 11, 2007 |