Tachos DR - Implantable Cardioverter Defibrillator.
FDA device recall Z-0700-03 · posted 2003-04-01 · Terminated
Recall details
- Recalling firm
- Biotronik Inc
- Reason for recall
- Potential for battery to delivery less than full amount of energy.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 240 (225 still implanted)
- Distribution
- The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
- Date initiated
- 2003-02-21
- Date posted
- 2003-04-01
- Date terminated
- 2003-09-08
- Location
- Lake Oswego, OR
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