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

Recall Z-0390-2019 — Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicate

U.S. FDA — Device Enforcement · United States · 2018-09-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0390-2019
Date of alert: 2018-09-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cordis Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 82144115

Reported risk: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).

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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