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Terminated

Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

FDA Recall Z-2435-2018 · Posted None

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeNPT
Date Initiated2018-06-11
Date Terminated2019-05-23
Product Quantity1 Valve

Reason for Recall

SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

Firm Action

On 06/11/2018, the firm sent an Urgent Product Recall notice, via sales representative hand delivery, to the customer requesting they return the customer response form and the affected device. The customer was advised to call Customer Service at 1-800-424-3278, if they had any additional questions.

Root Cause

Labeling False and Misleading

Distribution Pattern

NJ

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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