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

Recall Z-1290-2015 — Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

U.S. FDA — Device Enforcement · United States · 2015-03-04 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1290-2015
Date of alert: 2015-03-04
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Cardiovascular Systems, Inc.
Product category: device
Product type: Devices

Reported risk: The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.

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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