Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter — Class II medical device recall Z-0957-2022
Terminated recall by Abbott, reported 2022-04-27, distributed nationwide. Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the si
| Recall number | Z-0957-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2022-03-24 |
| Classified | 2022-04-19 |
| Reported by FDA | 2022-04-27 |
| Terminated | 2026-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, DK, ES, FR, GB, GR, IL, IT, JP, NL, NO, PL, PT, RU, SE, SK, TW |
| Quantity | 588 devices |
| UPC / GTIN / UDI-DI | 05415067027634 |
| Lot numbers | 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, 8207547 |
Product
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Reason for recall
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
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-0957-2022. 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.