Z-0505-2018 Class II Terminated
FDA device recall Z-0505-2018 was initiated by Cardiovascular Systems Inc on Sep 14, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Nov 4, 2019). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 14, 2018
- Initiation Date
- Sep 14, 2017
- Termination Date
- Nov 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
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.
Reason for Recall
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.
Distribution Pattern
FL, IL, MI, MN, MO, NY, SC, TX, and WI
Code Information
Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0505-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026