Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D
FDA device recall Z-0849-05 · posted 2005-05-18 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Llc
- Reason for recall
- Potential for deployment difficulties.
- Action taken
- 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
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 537
- Distribution
- Nationwide and Europe
- Date initiated
- 2005-04-28
- Date posted
- 2005-05-18
- Date terminated
- 2012-10-16
- Location
- Irvine, CA
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