CardiFocus Heartlight X3 Catheter- Intended in the treatment of… — Class II medical device recall Z-1307-2025
Ongoing recall by CardioFocus, Inc., reported 2025-03-19, distributed nationwide. Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
| Recall number | Z-1307-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CardioFocus, Inc., Marlborough, MA, United States |
| Recall initiated | 2025-02-07 |
| Classified | 2025-03-10 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CZ, GB, IT, JP |
| Quantity | 833 units |
| Reason classes | sterility |
| UPC / GTIN / 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 and 475 more |
| Model numbers | 18-5000 |
Product
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
Reason for recall
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1307-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.