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Terminated

ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.

FDA Recall Z-0935-05 · Posted 2005-06-25

Recalling FirmEv3
Recall StatusTerminated
Product CodeFGE
Date Initiated2005-06-10
Date Terminated2005-11-17
Product Quantity1

Reason for Recall

A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.

Firm Action

ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.

Root Cause

Other

Distribution Pattern

FL and PA

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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