Abbott TactiCath Sensor Enabled — Class II medical device recall Z-1344-2022
Terminated recall by Abbott, reported 2022-07-13, distributed nationwide. When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Cathete
| Recall number | Z-1344-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2022-06-09 |
| Classified | 2022-07-07 |
| Reported by FDA | 2022-07-13 |
| Terminated | 2026-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 191 devices |
| UPC / GTIN / UDI-DI | 05415067027665 |
| Lot numbers | 8409416, 8409675, 8410811 |
Product
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Reason for recall
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
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-1344-2022. 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.