Reported Mar 19, 2025 · Ongoing
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in…
CardioFocus, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CardioFocus, Inc. · 500 Nickerson Rd Ste 500-200 · Marlborough, MA · 01752-4698
Is this the product you have?
- CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology
- or Catheterization Laboratory Model18-5000
- Lot codes and dates
- UDI-DI00859373007433
- Serial NumbersLots shipped from January 2024 to January 2025
746 of 746 codes
231500123150022315003231500423150052315006231500723150082315009231501023150112315012231501323150142315015231501623150172315018231501923150202315501231550223155032315504231550523155062315507231550823155092315510231551123155122315513231551423155152315516231551723155182315519231700123170022317003231700423170052317006231700723170082317009231701023170112317012231701323170142317015231701623205012320502232050323205042320505
- Amount recalled
- 833 units
Where it was sold
- Nationwide
Why it was recalled
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
This product could cause temporary or reversible health problems — stop using it.
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