Abbott Recall 89872
Description: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Abbott Recall 89872 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0956-2022 |
| Event ID | 89872 |
| Event Description | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom. |
| Quantity | 2,134 devices |
| Recall Reason | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. |
| Device Classification | 20220427 |
| Device Code Info | Lot numbers: 8162700, 8164687, 8164730, 8172360, 8173365, 8173840, 8175413, 8177068, 8177349, 8177442, 8179358, 8179499, 8180723, 8180900, 8181043, 8182658, 8183581, 8183595, 8184393, 8184739, 8184817, 8186470, 8186747, 8186860, 8188124, 8188351, 8188844, 8190306, 8190438, 8191524, 8192181, 8192250, 8194325, 8195968, 8196343, 8196367, and 8197913. UDI (01)05415067027641(17)230331(10)xxxxxxx (lot number). |
| Center Classification Date | 20220419 |
| Recall Initiation Date | 20220324 |
| Recalling Firm | Abbott |
| Initial Notification | Letter |
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