ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.
FDA Recall Z-0912-06 · Posted 2006-05-31
Advertisement
Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2006-03-08
Date Terminated2007-02-03
Product Quantity29
Reason for Recall
A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
Firm Action
ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.
Root Cause
Other
Distribution Pattern
Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV
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.
Advertisement