FDA Medical Device Recalls (openFDA)
Edwards Lifesciences Research Medical Inc: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
- Recall number
- Z-0306-05
- Recalling firm
- Edwards Lifesciences Research Medical Inc
- Product
- EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
- Status
- Terminated
- Initiated
- 2004-11-19
- Posted
- 2004-12-15
- Terminated
- 2005-01-07
- Reason
- Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
- Root cause
- Other
- Action
- All consignees were notified by letter on 11/22/2004
- Quantity
- 396 units
- Distribution
- AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.
- Lot, serial or model codes
- Model EX24D, Lot No.: 58174875
- 510(k) numbers
- ["K020693"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1713910
- Firm city
- Midvale
- Firm state
- UT
- 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