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

Recall Z-2033-2017 — Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

U.S. FDA — Device Enforcement · United States · 2015-11-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2033-2017
Date of alert: 2015-11-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Terumo Medical Corporation
Product category: device
Product type: Devices

Reported risk: Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.

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

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Recall Z-2033-2017 — Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

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