FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
- Recall number
- Z-1749-2013
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
- Status
- Terminated
- Initiated
- 2013-06-19
- Posted
- 2013-07-17
- Terminated
- 2014-11-04
- Reason
- Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
- Root cause
- Component design/selection
- Action
- Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken appropriate action by completing, sign and dating the enclosed Recall Response Form and returning the form to Edwards by fax to Edwards Customer Service at 800-422-9329. Customers should contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number to return their current product to and receive replacement product. Customers with questions were instructed to call Edwards Customer Service at 800-424-3278.
- Quantity
- S099: 171,587 units and S099B: 505,107 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
- Lot, serial or model codes
- Models S099 and S099B
- 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
- 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
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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