Z-2435-2018Class II

Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

Name: Z-2435-2018 Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Creator: Edwards Lifesciences, LLC
Published: 2018-06-11
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2018-06-11 / Terminated / root cause: labeling and UDI

FDA source

Edwards Lifesciences, LLC began a recall of Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm on 2018-06-11. FDA classified it as Class II and gives the reason as "SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2435-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-11
Posted: 2018-07-13
Terminated: 2019-05-23
Recalling firm: Edwards Lifesciences LLC
Product: Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Reason for recall: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On 06/11/2018, the firm sent an Urgent Product Recall notice, via sales representative hand delivery, to the customer requesting they return the customer response form and the affected device. The customer was advised to call Customer Service at 1-800-424-3278, if they had any additional questions.
Quantity in commerce: 1 Valve
Distribution: NJ
Product codes and lots: Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2435-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2435-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13

Product code NPT

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)