Z-1290-2015 Class I Terminated
FDA device recall Z-1290-2015 was initiated by Cardiovascular Systems, Inc. on Mar 4, 2015 and is designated Class I. 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… The recall status is terminated (terminated Apr 26, 2016). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 1, 2015
- Initiation Date
- Mar 4, 2015
- Termination Date
- Apr 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
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.
Distribution Pattern
Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
Code Information
107046, 106992, 106993, 106990.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1290-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026