FDA Device recall Z-0506-2018
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at… by Cardiovascular Systems, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0506-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-14 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardiovascular Systems |
| Distribution | FL, IL, MI, MN, MO, NY, SC, TX, WI |
Product
Peripheral Diamondback 1.50 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
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.
Identifiers
| code_info | Lot # 190217 Part #: 7-10011 Model # DBP-150SOLID145 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Cardiovascular Systems
- WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
FDA Device · Class I · 2021-12-29 · Cardiovascular Systems - DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000
FDA Device · Class II · 2018-09-19 · Cardiovascular Systems - Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
FDA Device · Class II · 2018-02-14 · Cardiovascular Systems
All Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0506-2018%22
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