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

Recall Z-0188-2018 — Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel di

U.S. FDA — Device Enforcement · United States · 2017-11-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0188-2018
Date of alert: 2017-11-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00821684051436

Reported risk: Stent length on the label may not match the length of the stent itself.

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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