April 29, 2019 — 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.
The Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter are used by healthcare providers to enlarge the opening between the atria of the heart. 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.
The Class I recall includes model numbers 830515F and 830705F of the indicated devices, with lot numbers including all lots expiring within 15 months. See the full list of affected lot numbers here. All impacted devices were manufactured between Dec. 22, 2017 and Jan. 18, 2019; they were distributed between Jan. 9, 2018 and Feb. 25, 2019.
An Urgent Product Recall notice from Edwards Lifesciences 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; and
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.
Healthcare 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.
For more information: www.edwards.com