TactiFlex Sensor Enabled Ablation Catheter — Class I medical device recall Z-0113-2026
Ongoing recall by Abbott, reported 2025-10-22. Abbott has become aware of a limited number of tip detachment events during catheter removal from the packagin
| Recall number | Z-0113-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2025-09-10 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Quantity | 1,960 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05415067034670 |
| Lot numbers | 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567, 10371569, 10371577, 10399929, 10418884, 10418885, 10418895, 10429561, 10429563, 10479188, 10479190, 10482343, 10482351, 10482363, 10482378, 10513080, 10533833, 10533851, 10533854, 10566078, 10597230, 10646250, 10646251, 10646253, 10673213 and 36 more |
Product
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Reason for recall
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
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-0113-2026. 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.