The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter
- Model Numbers: 830515F and 830705F
- Lot Numbers: All lots expiring within 15 months. Lot numbers include: 59971507, 61068488, 61135027, 61176259, 61176335, 61209914, 61230764, 61245298, 61252231, 61252473, 61288724, 61332460, 61339380, 61350747, 61371827, 61393284, 61408923, 61415949, 61427629, 61453869, 61478583, 61481224, 61491734, 61516358, 61524807, 61532783, 61542460, 61552718, 61561749, 61569309, 61579845, 61719588, 61825706, 61846022, 61135026, 61046484, 61146229, 61176182, 61230763, 61252229, 61252230, 61252471, 61270367, 61321210, 61329796, 61350746, 61361008, 61369040, 61435190, 61444420, 61491732, 61516362, 61532782, 61542459, 61561748, 61569308, 61687687, 61697835, 61731942, 61809420.
- Manufacturing Dates: December 22, 2017 to January 18, 2019
- Distribution Dates: January 9, 2018 to February 25, 2019
- Date Initiated by Firm: March 28, 2019
The Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter are used by health care providers to enlarge the opening between the two upper chambers of the heart (the atria). This is done either to increase oxygenated/deoxygenated blood mixing, which then improves the baby’s overall oxygen level, or to decompress one of the atria when drainage is obstructed, which then improves blood flow and cardiac output.
Reason for Recall
Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death. One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon. There were no deaths reported.
Who is affected?
- Healthcare providers using the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter
- Patients undergoing procedures involving the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter
What to Do
On March 28, 2019, Edwards Lifesciences sent an Urgent Product Recall notice to affected customers. The notice asked customers to:
- Identify inventory and remove any affected products
- If you have unused product to return, contact Edwards Customer Service at 1-800-424-3278 option 1, to obtain a Returned Good Authorization (RGA) number.
- Complete the acknowledgement form and fax to Edwards Customer Service at 1-800-422-9329 or 949-809-5467 within 10 days from receipt of the notification.
- If you have no product to return, indicate "0" on the acknowledgment form.
Customers who have questions or need additional information or support regarding this recall should contact Edwards Customer Service at 1-800-424-3278, option 1.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.