Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1959-2012 — 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

U.S. FDA — Device Enforcement · United States · 2012-06-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1959-2012
Date of alert: 2012-06-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardiovascular Systems, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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