FDA Device recall Z-0957-2022
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile
- FDA Device
- Class II
- terminated
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile by Abbott, citing devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0957-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-24 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott |
| Distribution | US |
Product
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Reason
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Identifiers
| code_info | Lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 820576…Lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. UDI (01)05415067027634(17)230331(10)xxxxxxx (lot number). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0957-2022%22
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