Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected:
FDA device recall Z-0689-2008 · posted 2008-04-08 · Terminated
Recall details
- Recalling firm
- Medtronic CardioVascular
- Reason for recall
- Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.
- Action taken
- Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MIH
- Quantity affected
- 7,000
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-12-10
- Date posted
- 2008-04-08
- Date terminated
- 2008-07-28
- Location
- Santa Rosa, CA
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