FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
- Recall number
- Z-2435-2018
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
- Status
- Terminated
- Initiated
- 2018-06-11
- Posted
- not on file
- Terminated
- 2019-05-23
- Reason
- SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
- 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
- 1 Valve
- Distribution
- NJ
- Lot, serial or model codes
- Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
- 510(k) numbers
- not on file
- PMA numbers
- ["P140031"]
- Product code
- NPT
- 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