Recall Z-1290-2015— Cardiovascular Systems, Inc.
Class I · Terminated
Class I FDA medical device recall by Cardiovascular Systems, Inc., initiated 2015-03-04, terminated 2016-04-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Cardiovascular Systems, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-03-04
- Terminated
- 2016-04-26
- Firm location
- Saint Paul, MN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.