CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation
Medical device recall Z-1307-2025. Published in FDA’s Enforcement Report on Mar 19, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 19, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 833 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
833 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00859373007433 Serial Numbers: 2315001 2315002 2315003 2315004 2315005 2315006 2315007 2315008 2315009 2315010 2315011 2315012 2315013 2315014 2315015 2315016 2315017 2315018 2315019 2315020 2315501 2315502 2315503 2315504 2315505…
Every code shown here, 1,999 characters
UDI-DI: 00859373007433 Serial Numbers: 2315001 2315002 2315003 2315004 2315005 2315006 2315007 2315008 2315009 2315010 2315011 2315012 2315013 2315014 2315015 2315016 2315017 2315018 2315019 2315020 2315501 2315502 2315503 2315504 2315505 2315506 2315507 2315508 2315509 2315510 2315511 2315512 2315513 2315514 2315515 2315516 2315517 2315518 2315519 2317001 2317002 2317003 2317004 2317005 2317006 2317007 2317008 2317009 2317010 2317011 2317012 2317013 2317014 2317015 2317016 2320501 2320502 2320503 2320504 2320505 2320506 2320507 2320508 2320509 2320510 2320511 2320512 2320513 2320514 2320515 2320516 2320517 2320518 2320519 2320520 2323001 2323002 2323003 2323004 2323005 2323006 2323007 2323008 2323009 2323010 2323101 2323102 2323103 2323104 2323105 2323106 2323107 2323108 2323109 2323110 2325001 2325002 2325003 2325004 2325005 2325006 2325007 2325008 2325009 2325010 2325011 2325012 2325013 2325014 2325015 2327201 2327202 2327203 2327204 2327205 2327206 2327207 2327208 2327209 2327210 2328101 2328102 2328103 2328104 2328105 2328106 2328107 2328108 2328109 2328110 2328111 2332101 2332102 2332103 2332104 2332105 2332106 2332107 2332108 2332109 2332110 2332111 2332112 2332113 2332114 2332115 2332116 2332117 2332118 2332119 2332120 2338701 2338702 2338703 2338704 2338705 2338706 2338707 2338708 2338709 2338710 2338711 2338712 2338713 2338714 2338715 2338716 2338717 2338718 2338719 2338720 2339201 2339202 2339203 2339204 2339205 2339206 2339207 2339208 2339209 2339210 2339211 2339212 2339213 2339214 2343001 2343002 2343003 2343004 2343005 2343006 2343007 2343008 2343009 2343010 2343016 2343017 2343018 2343019 2343020 2344501 2344502 2344503 2344504 2344505 2344506 2344507 2344508 2344509 2344510 2344511 2344512 2344513 2344514 2344515 2344516 2344517 2344518 2344519 2344520 2346001 2346002 2346003 2346004 2346005 2346006 2346007 2346008 2346009 2346010 2346011 2346012 2347301 2347302 2347303 2347304 2347305 2347306 2347307 2347308 2347309 2347310 2347311 2347312 2347313…
FDA’s list runs to 6,053 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 7, 2025.
- FDA classified it on Mar 10, 2025.
- FDA’s Enforcement Report published it on Mar 19, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CardioFocus, Inc., of Marlborough, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,053 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.