FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
- Recall number
- Z-0238-2024
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
- Status
- Open, Classified
- Initiated
- 2023-09-07
- Posted
- 2023-11-06
- Terminated
- not on file
- Reason
- Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
- Root cause
- Nonconforming Material/Component
- Action
- On 9/7/23, correction notices were sent to customers informing them to take the following actions: 2) Return affected devices. 3) Forward notice to any of your customers who have purchased the impacted devices. 3) Complete and return the acknowledgement form.
- Quantity
- 185
- Distribution
- OUS: Singapore, Taiwan, Canada
- Lot, serial or model codes
- UDI-DI: 00690103043532, Lot: 64936927
- 510(k) numbers
- K892410
- PMA numbers
- not on file
- Product code
- DXE
- 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