CSI Stealth 360-degree Orbital Atherectomy Device — Class II medical device recall Z-1959-2012
Terminated recall by Cardiovascular Systems, Inc., reported 2012-07-18, distributed nationwide. CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which hav
| Recall number | Z-1959-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems, Inc., Saint Paul, MN, United States |
| Recall initiated | 2012-06-18 |
| Classified | 2012-07-09 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2012-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 27 |
| Reason classes | device malfunction |
| Lot numbers | 59887, 59888, 61516, 61517 |
| Model numbers | 70056-11, PRD-SC30-125S |
Product
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is 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
CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1959-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.