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Terminated

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 Recall Z-1117-2019 · Posted 2019-04-25

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDXF
Date Initiated2019-03-28
Date Terminated2023-11-01
Product Quantity1564

Reason for Recall

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

Firm Action

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.

Root Cause

Process design

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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