Reported Apr 1, 2015 · Terminated
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate…
Cardiovascular Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiovascular Systems, Inc. · 651 Campus Dr · Saint Paul, MN · 55112-3495
Is this the product you have?
- Diamondback 360 Coronary Orbital Atherectomy System
- Model NumberDBEC-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
- Lot codes and dates
107046106992106993106990
- Amount recalled
- 30
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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