Use cautionMedical device recall · FDA · Published March 28, 2019
Edwards Lifesciences Miller Balloon Catheter Recall: Balloon Deflation Issues
Edwards Lifesciences recalls Miller Balloon Atrioseptostomy Catheters with risk of balloon fragmentation after deployment. Affected units have REF: 830515F and expired within 15 months of 03/01/2019.
“Edwards Lifesciences Miller Balloon Catheter Recall: Balloon Deflation Issues.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68539-edwards-lifesciences-miller-balloon-catheter-recall-balloon-deflation-issues. Based on FDA recall #Z-1117-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1117-2019%22&limit=1).
Edwards Lifesciences, LLC recalled the Miller Balloon Atrioseptostomy Catheter on March 28, 2019, according to the FDA. The device poses a hazard of balloon deflation difficulty and fragmentation. Owners should contact the company for details.
How to tell if you have it
Brand: Edwards Lifesciences
Product: Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only
REF: 830515F
Lots within 15 months expiry from 03/01/2019
The hazard
The recall addresses difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Context
GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since 2017-07-06. Other recent recalls include the Edwards EVOQUE Tricuspid Delivery System Recall (2026-03-27), the Edwards FEM-FLEX II Femoral Arterial Cannula Recall (2025-05-14), and the Edwards Lifesciences FloTrac Sensor Recall (2023-10-04). Other recent recalls of similar products include the Microvention Bobby Balloon Guide Catheter Recall (2026-04-30), the LeMaitre TufTex Catheter Recall (2026-08-28), and the Medline Medical Procedure Kits Recall (2026-05-04).
How to tell if you have this one
Check for the product reference number REF: 830515F. The catheter was sold with an expiration date within 15 months of March 1, 2019.
Brand
Edwards Lifesciences
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
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 number
Product, codes & lots
Quantity
Z-1116-2019
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation 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.; All lots within 15 months expiry from 03/01/2019
1093
Z-1117-2019
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.; All lots within 15 months expiry from 03/01/2019
1564
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the reference number REF: 830515F and expiration date within 15 months of March 1, 2019.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 32 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 4.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1117-2019 (March 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1117-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.