—#171709

Product

Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidance and has been carried out after the diagnosis of several congenital cardiac defects including but not limited to: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, and pulmonary atresia with intact ventricular septum.

FDA product code: DXF — Catheter, Septostomy
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: All lots within 15 months expiry from 03/01/2019

Why it was recalled

Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.

Root cause (FDA determination)

Process design

Action the firm took

On 03/28/19, Urgent Product Recall - Action Required Field Corrective Action notices were mailed FedEx Second Day to customers. The letter identified the affected product problem and actions to be taken. The firm is requesting the return of any existing inventory of these models. They are conducting an investigation of the issues. At this time, they do not have an estimated date as to when replacement product will become available. The firm urges customers to inquire as to the availability of similar products. Customers with additional questions are encouraged to call 800-424-3278 Option 1. Firm requests that customers fill out and return Customer Acknowledgement forms within 10 days of receipt of this notification.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of : IA, FL, MD, CA, NY, TX, CT, NC, OR, LA, UT,AK, WA, AZ, SD,CO,IN, KY, WV, TN, MI, AL, MA, VA, PA, MO, IL, GA, PR, MN, AR, OK, WI. Foreign (OUS): CL, AR, CZ, SG, BR, ID, ES, IE, GB, AT, CA, AM, HK, AU, ZA, FI, KR, MY, TH, NL, FR, IT, GR, DK, SE, DE, TR, QA, NZ, SA, PS, PT, JP, CH, IL, AE, BE, EE

Timeline

Recall initiated: 2019-03-28
Posted by FDA: 2019-04-25
Terminated: 2023-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171709. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.