Recall Z-0351-03 ยท 74
Medtronic Cardiac Surgery Technologies
Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47
| Date | Nov 11, 2002 |
| Status | Terminated |
| Reason | The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device. |
| Root cause | Other |
| Action | A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives. |
| Quantity | 148 pens |
| Distribution | All of the consignees were in foreign countries in Europe, Asia and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013392 | CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 Medtronic Vascular, Jan 25, 2002 |