Edwards Lifesciences recall
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy…
Why was Edwards Lifesciences recalled?
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots within 15 months expiry from 03/01/2019
- Product
- Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 1093
- Distribution
- 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
- Recall date
- May 1, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)