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RecallWatchMedical Device Safety
Class IIOngoingZ-1307-2025

CardioFocus, Inc. recalls CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It…

CardioFocus, Inc.Marlborough, MA, United StatesReported Mar 19, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI 00859373007433
    400 affected lots
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What the firm is doing

CardioFocus issued via email on 2/7/25 Urgent Field Safety Notice. Letter states reason for recall, health risk and action to take: Please forward the provided field safety notice to all individuals within the organization who need to be made aware. We request you immediately check all stock and operating room storage for affected devices, quarantine and discontinue use of affected devices. Please complete the attached Customer Reply Form and return it at your earliest convenience. Actions to be taken by CardioFocus: CardioFocus will send our team to perform an onsite inspection of your inventory and provide replacement devices for any products identified as damaged. The primary contact for this FSCA is Jenny Xia of CardioFocus. Her phone number is 508-658-7200, her cell phone is (603) 897-5787 and e-mail address is jxia@cardiofocus.com. Can be contacted Monday through Friday, from 8 AM ET to 5 PM ET.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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