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

Recall Z-0818-2017 — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

U.S. FDA — Device Enforcement · United States · 2016-10-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0818-2017
Date of alert: 2016-10-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Oscor, Inc.
Product category: device
Product type: Devices

Reported risk: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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-0818-2017 — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

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