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Terminated

Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis

FDA Recall Z-0835-2019 · Posted None

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeNPT
Date Initiated2019-01-22
Date Terminated2019-03-26
Product Quantity159,448 units

Reason for Recall

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

Firm Action

The firm began disseminating the notices by letter on 01/22/2019. The notices explained the issue and advised the consignee to follow the guidelines and instructions provided in the Edward SAPIEN3 Commander delivery system training material for device preparation and use. Updated instructions for use will be disseminated in the near future.

Root Cause

Labeling design

Distribution Pattern

WorldwideDistribution

Official Source

View FDA Recall →

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

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