Recall Z-1437-04 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Biosense Webster, Inc.
Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.
| Date | Sep 2, 2004 (initiated Aug 16, 2004) |
| Status | Terminated |
| Reason | Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire. |
| Root cause | Other |
| Action | Sales Representative to provide letter to each of the 25 US customers explaining the action. Sales Representatives will remove any affected product from customers inventory. Certification records will be completed for each customer confirming the removal action. International affiliates to conduct similar actions. |
| Quantity | 848 |
| Distribution | Nationwide and Japan, Europe, & Uruguay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.