Recall Z-0207-05 ยท DTA Tester, Pacemaker Electrode Function
Medtronic Inc. Cardiac Rhythm Managment
Medtronic CapSureFix Novus Lead Model 5076.
| Date | Nov 17, 2004 (initiated Oct 20, 2004) |
| Status | Terminated |
| Reason | A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length. |
| Root cause | Other |
| Action | Letter of October 20, 2004, to direct customers, advised them to work with their respective Medtronic representatives to locate all leads and return them to Medtronic. |
| Quantity | 35 incorrectly labeled leads were distributed to customers. |
| Distribution | Leads were distributed to 21 consignees (hospitals/clinics) throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.