TactiCath Quartz Contact Force Ablation Catheter — Class II medical device recall Z-2541-2020
Terminated recall by Abbott, reported 2020-07-15. High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Co
| Recall number | Z-2541-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2020-05-22 |
| Classified | 2020-07-09 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-02-11 |
| Quantity | 84,104 devices |
| UPC / GTIN / UDI-DI | 07640157990033, 07640157990040 |
| Model numbers | 065, PN-004 |
| Expiration dates | 2020-04-25 |
Product
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.
Reason for recall
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation 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-2541-2020. 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.