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Terminated

Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)

FDA Recall Z-1330-04 · Posted 2004-08-07

Recalling FirmEv3
Recall StatusTerminated
Product CodeFGE
Date Initiated2004-07-09
Date Terminated2006-12-28
Product Quantity11

Reason for Recall

Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018').

Firm Action

Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.

Root Cause

Other

Distribution Pattern

Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033314PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEMEv3, Inc. · 2003-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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