Recall Z-1191-2007 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Boston Scientific Corp
Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
| Date | Aug 22, 2007 (initiated Jun 26, 2007) |
| Status | Terminated |
| Reason | Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes). |
| Root cause | Labeling mix-ups |
| Action | The firm issued notification letters to its consignees, sent 06/26/2007, via FedEx. The firm intends to remove the product and destroy it. |
| Quantity | 30 units |
| Distribution | Product was distributed to 3 consignees in Florida and Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924163 | EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC Boston Scientific Corp, Sep 3, 1993 |