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.
FDA Recall Z-1095-2014 · Posted 2014-02-26
Advertisement
Recalling FirmCardiovascular Systems, Inc.
Recall StatusTerminated
Product CodeMCX
Date Initiated2014-01-27
Date Terminated2014-05-05
Product Quantity318
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
Firm 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.
Root Cause
Process control
Distribution Pattern
USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement