Class I Recall of Edwards Lifesciences Recalls Miller and Fogarty Atrioseptostomy Dilation Catheters
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.
- Recalled Product(s): Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter
- Model Numbers: 830515F and 830705F
- Lot Numbers: see recall notice
- Manufacturing Dates: December 22, 2017 to January 18, 2019
- Distribution Dates: January 9, 2018 to February 25, 2019
- Devices Recalled in the U.S.
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.
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