FDAFebruary 7, 2025device
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
What to do
FDA enforcement status: Ongoing
Brands named
cardiofocus
UPCs
00859373007433
Recall history
No related federal recalls on record for this brand yet.
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