Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent

FDA device recall Z-1290-2015 · posted 2015-03-20 · Terminated

Recall details

Recalling firm

Cardiovascular Systems, Inc.

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MCX

Quantity affected

30

Distribution

Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.

Date initiated

2015-03-04

Date posted

2015-03-20

Date terminated

2016-04-26

Location

Saint Paul, MN