Z-1117-2019 Class I Terminated
FDA device recall Z-1117-2019 was initiated by Edwards Lifesciences, LLC on March 28, 2019 and is designated Class I. Reason for recall: Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. The recall status is terminated (terminated November 1, 2023). Affected quantity: 1564.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- March 28, 2019
- Termination Date
- November 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1564
Product Description
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.
Reason for Recall
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
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
Code Information
All lots within 15 months expiry from 03/01/2019