Recall Z-0700-03 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Biotronik Inc
Tachos DR - Implantable Cardioverter Defibrillator.
| Date | Apr 1, 2003 (initiated Feb 21, 2003) |
| Status | Terminated |
| Reason | Potential for battery to delivery less than full amount of energy. |
| Root cause | Other |
| Action | The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians. This letter explains the issue and recommends scheduling an immediate follow-up with the patients. The letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted. |
| Quantity | 240 (225 still implanted) |
| Distribution | The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.