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

Recall Z-1705-2019 — IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascen

U.S. FDA — Device Enforcement · United States · 2019-05-14 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1705-2019
Date of alert: 2019-05-14
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Edwards Lifesciences, LLC
Product category: device
Product type: Devices

Reported risk: Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

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.

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