Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. 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.
This recall has been terminated (originally issued March 20, 2015).
- Company
- Cardiovascular Systems Inc
- Recall Initiated
- March 4, 2015
- Posted
- March 20, 2015
- Terminated
- April 26, 2016
- Recall Number
- Z-1290-2015
- Quantity
- 30
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
Distribution
Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
Lot / Code Info
107046, 106992, 106993, 106990.
Root Cause
Nonconforming Material/Component
Action Taken
Consignees were sent on 3/4/2015 a CSI "Urgent Medical Device Recall" letter dated March 04, 2015. The letter described the problem and the affected product. Consignees were advised to remove and return the affected product to CSI. The letter also requested consignees to complete and return the Customer Acknowledgement Form by Fax or with the RGA (Returned Goods Authorization). For further information they can contact Customer Service, Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton, MN 55112, 877-274-0901 -Tel, 612-677-3355- Fax.