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

Recall Z-0333-2017 — Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

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-0333-2017
Date of alert: 2016-10-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Neurovascular
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 18709130

Reported risk: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.

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-0333-2017 — Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

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