Recall Z-0618-03 ยท DQY Catheter, Percutaneous
Medtronic,Inc/Rice Creek Facil
Atakr II RF Power Generator, Models 4802 and 4803
| Date | Mar 6, 2003 (initiated Nov 25, 2002) |
| Status | Terminated |
| Reason | An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances. |
| Root cause | Other |
| Action | An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem. |
| Quantity | 775 units |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.