Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic
FDA device recall Z-0709-05 · posted 2005-04-13 · Terminated
Recall details
- Recalling firm
- St Jude Medical
- Reason for recall
- Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery.
- Action taken
- Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIK
- Quantity affected
- 1488
- Distribution
- Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
- Date initiated
- 2005-03-10
- Date posted
- 2005-04-13
- Date terminated
- 2005-07-11
- Location
- Sylmar, CA
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