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

Recall Z-1230-2017 — DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arter

U.S. FDA — Device Enforcement · United States · 2016-12-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1230-2017
Date of alert: 2016-12-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardiovascular Systems Inc
Product category: device
Product type: Devices

Reported risk: CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

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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