FDAFDA · Food and drugs·Recall number Z-1290-2015
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.
Published April 1, 2015 · Recall initiated: March 4, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardiovascular Systems, Inc.
- Distributor
- Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
- Lot
- 107046, 106992, 106993, 106990.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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