FDA Medical Device Recalls (openFDA)
Edwards Lifesciences Llc: 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)
- Recall number
- Z-0849-05
- Recalling firm
- Edwards Lifesciences Llc
- Product
- 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)
- Status
- Terminated
- Initiated
- 2005-04-28
- Posted
- 2005-05-18
- Terminated
- 2012-10-16
- Reason
- Potential for deployment difficulties.
- Root cause
- Other
- 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.
- Quantity
- 537
- Distribution
- Nationwide and Europe
- Lot, serial or model codes
- All codes.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MAF
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28