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

Recall Z-2039-2020 — Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

U.S. FDA — Device Enforcement · Ireland · 2020-05-12 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2039-2020
Date of alert: 2020-05-12
Country / jurisdiction: Ireland
Risk level: Class I
Risk type: recall
Brand: Medtronic Vascular Galway DBA Medtronic Ireland
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00763000233815

Reported risk: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

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.

Recall Z-2039-2020 — Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

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