Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-19
FDA device recall Z-1017-05 · posted 2005-07-19 · Terminated
Recall details
- Recalling firm
- St Jude Medical
- Reason for recall
- Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.
- Action taken
- Recall was by letter to Physicians sent by FEDEX. Follow-up upgrade to programmers will be done by firm representatives to the new version 4.8.5.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIK
- Quantity affected
- 30,000 domestically, 11,684 internationally
- Distribution
- Nationwide and Sweden, Canada, Australia, New Zealand. South America and Asia
- Date initiated
- 2005-06-17
- Date posted
- 2005-07-19
- Date terminated
- 2012-03-26
- Location
- Sylmar, CA
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