CardioFocus recalls Heartlight X3 catheters (model 18-5000) with potential sterile pouch damage risking infection. Affected units shipped Jan 2024-Jan 2025. Stop using if you have these serial numbers.
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
CardioFocus is recalling Heartlight X3 catheters that may have damaged sterile pouches, risking infection during medical procedures. This affects specific units shipped between January 2024 and January 2025.
The catheter's sterile barrier pouch could become damaged during manufacturing or handling, potentially compromising sterility. This might lead to infections during medical procedures if the device is used without proper sterilization.
Healthcare professionals using these catheters in electrophysiology labs. Patients receiving atrial fibrillation treatment with this device are most at risk.
Check for serial numbers starting with 2315001-2362210 or ending with 2463311. These units were shipped from January 2024 to January 2025.
If you have a Heartlight X3 catheter with the affected serial numbers, stop using it immediately to prevent potential infection risks.
The model number is 18-5000.
Check the serial number on your catheter. Affected units have serial numbers starting with 2315001-2362210 or ending with 2463311, shipped between January 2024 and January 2025.
The recall does not specify a return process, but you should stop using it immediately if you have an affected unit.
We’ve drafted a message you can send CardioFocus to request your refund or repair — edit it as you like.
Subject: Recall Z-1307-2025 — CardioFocus CardioFocus Hello, I own a CardioFocus that is covered by recall Z-1307-2025 from CardioFocus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
