ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
FDA Recall Z-0389-2007 · Posted 2007-02-01
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Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2006-12-06
Date Terminated2007-02-03
Product Quantity2
Reason for Recall
Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
Firm Action
Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.
Root Cause
Other
Distribution Pattern
IL, PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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