—#188261

Product

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532

FDA product code: DQE — Catheter, Oximeter, Fiber-Optic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K053609
Affected lot / code info: LOT NUMBERS: 62685549, 62728569, 62889136, 62903838, 63256058, 62728569, 62889136, 62903838, 62939833, 62452820, 62661574, 62420335, 62889136, 63256058, 62452820, 62661574, 62685549, 62728569, 62420335, 62420335, 62452820, 62420335, 62452820, 62661574, 62889136, 62903838, 63600994, 63608318, 63608323, 62661574, 62420335, 62661574, 62903838

Why it was recalled

There is a potential for internal leaks within catheters.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2021-07-09
Terminated: 2024-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188261. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.