VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corp
FDA device recall Z-0954-05 · posted 2005-06-30 · Terminated
Recall details
- Recalling firm
- Boston Scientific CRM Corp
- Reason for recall
- The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
- Action taken
- Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWP
- Quantity affected
- 937 devices (714 currently implanted worldwide)
- Distribution
- worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan
- Date initiated
- 2005-06-17
- Date posted
- 2005-06-30
- Date terminated
- 2008-03-02
- Location
- Saint Paul, MN
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