Recall Z-1117-2019— Edwards Lifesciences, LLC
Class I · Terminated
Class I FDA medical device recall by Edwards Lifesciences, LLC, initiated 2019-03-28, terminated 2023-11-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-03-28
- Terminated
- 2023-11-01
- Firm location
- Irvine, CA, United States
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.
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