CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The
FDA device recall Z-1095-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Cardiovascular Systems, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- MCX
- Quantity affected
- 318
- Distribution
- USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
- Date initiated
- 2014-01-27
- Date posted
- 2014-02-26
- Date terminated
- 2014-05-05
- Location
- Saint Paul, MN
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