FDA Medical Device Recalls (openFDA)
Edwards Lifesciences Research Medical, Inc.: Aortic Perfusion Cannula with plastic tip, 22 Fr. x 23 cm, Edwards Lifesciences
- Recall number
- Z-1093-06
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Product
- Aortic Perfusion Cannula with plastic tip, 22 Fr. x 23 cm, Edwards Lifesciences
- Status
- Terminated
- Initiated
- 2006-04-18
- Posted
- 2006-06-09
- Terminated
- 2008-06-11
- Reason
- Due to potential embrittlement of the plastic tip which may crack or separate during use.
- Root cause
- Other
- Action
- Consignees were notified by letter and visit beginning 04/18/2006.
- Quantity
- 240 units (Foreign)
- Distribution
- CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
- Lot, serial or model codes
- REF: AH221190A. Lot number 58200588.
- 510(k) numbers
- ["K831769"]
- 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