Device product
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Z-0505-2018
Product summary
- Event
- Event 78897
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-0505-2018
Official wording
Reason: Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
Code information: Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145
Distribution pattern: FL, IL, MI, MN, MO, NY, SC, TX, and WI
Derived failure modes
-
Unknown
Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.