Diamondback 360 Coronary Orbital Atherectomy System recall
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with…
Why was Diamondback 360 Coronary Orbital Atherectomy System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
107046, 106992, 106993, 106990.
- Product
- Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with…
- Recalling firm
- Cardiovascular Systems, Inc.
- Quantity
- 30
- Distribution
- Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
- Recall date
- April 1, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)