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Terminated

Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)

FDA Recall Z-0849-05 · Posted 2005-05-18

Recalling FirmEdwards Lifesciences Llc
Recall StatusTerminated
Product CodeMAF
Date Initiated2005-04-28
Date Terminated2012-10-16
Product Quantity537

Reason for Recall

Potential for deployment difficulties.

Firm Action

Recall was by voice mail and regular postal service on 4/28/2005 in the USA, in Europe recall began May 2, 2005. Recall notification is complete, unused product is being returned.

Root Cause

Other

Distribution Pattern

Nationwide and Europe

Official Source

View FDA Recall →

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

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