FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.
- Recall number
- Z-1967-2012
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.
- Status
- Terminated
- Initiated
- 2012-06-06
- Posted
- 2012-07-09
- Terminated
- 2012-09-10
- Reason
- Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.
- Root cause
- Process control
- Action
- Edwards Lifesciences sent an Urgent Field Safety Notice Product Recall letter dated June 2012 to all affected customers. The letter identified the affected product, description of the issue and actions to be taken. Customers were instructed to examine their inventory for the affected product, quarantine and return any remaining in stock and complete the enclosed acknowledgment form with fax instructions to assure that the notification was received. For question call Edwards Customer Service at (800) 424-3278 from 8:00AM-4:30PM Pacific Time.
- Quantity
- 1524 units
- Distribution
- Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.
- Lot, serial or model codes
- Lot numbers: 58749813, 58802303, 58836847, 58877405, 58909346, 59011910, 59035360, 59085935, 59118391, 59241531, 58705682, 58711964, 58722234, 58771175, 58837337, 58855247, 58904182, 58927518, 58936037, 58936014, 58936027, 59009635, 59030253, 59056470, 59103213, 59124020, 59199172, 59218725, 59235997.
- 510(k) numbers
- K831759
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1713910
- Firm city
- Draper
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06