FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
- Recall number
- Z-2282-2021
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
- Status
- Terminated
- Initiated
- 2021-07-09
- Posted
- not on file
- Terminated
- 2024-01-29
- Reason
- There is a potential for internal leaks within catheters.
- Root cause
- Process control
- Action
- On 7/9/2021 Edwards issued a "URGENT MEDICAL DEVICE PROUDCT CORRECTION" via FedEx to all affected consignees. In addition to informing consignees about the recall the firm ask consignees take the following actions: 1. The problem may be identified during preparation of the catheter for insertion per the IFU, paying specific attention to the connection between the green hub and the tubing for any signs of leakage. Additionally, the problem may be identified if when flushing the lumens of the catheter while administering a medication, a transient change of vital signs is observed. In either of these situations, remove the catheter over a guidewire maintaining venous access and then place a new product over the venous wire. Once properly placed, remove the guidewire, and secure the catheter. New venous access is not required. 2. Please follow the instructions included in the enclosed acknowledgement form and listed below. Return the acknowledgement form to US.FCA@edwards.com. 3. There is no need to return product at this time. 4. Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. 5. E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com within 5 days from receipt of this notification. Product can be used as indicated above. If you have any questions, you may call Customer Service at 1-800-424-3278 option 1, from 5AM 4:30PM PST. 6. Advice on action to be taken by Distributor: 7. Please review this letter and complete the acknowledgement form. Return the acknowledgement form to US.FCA@edwards.com. Please forward this customer communication to any of your customers who have purchased the impacted Edwards PediaSat product and ask them to return the enclosed acknowledgement form. 8. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product and Edwards will communicate directly with your customers to facilit
- Quantity
- 50 units
- Distribution
- US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada
- Lot, serial or model codes
- Lot Numbers: 62889103, 62939785, 62954623, 63435579, 63439594
- 510(k) numbers
- ["K053609"]
- PMA numbers
- not on file
- Product code
- DQE
- 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