Z-0849-05

Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D)...

Name: Z-0849-05 Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D)...
Creator: Edwards Lifesciences Llc
Published: 2005-04-28
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2005-04-28 / Terminated

FDA source

Edwards Lifesciences Llc began a recall of Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902... on 2005-04-28. The reason FDA records is "Potential for deployment difficulties". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0849-05
Status: Terminated
Initiated: 2005-04-28
Posted: 2005-05-18
Terminated: 2012-10-16
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)
Product code: MAF Stent, Coronary
Reason for recall: Potential for deployment difficulties.
FDA 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 in commerce: 537
Distribution: Nationwide and Europe
Product codes and lots: All codes.

Product code MAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)