Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000.

FDA Recall Z-1121-2008 · Posted 2008-05-06

Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-01-18
Date Terminated2008-11-04
Product Quantity23

Reason for Recall

Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

Firm Action

ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980290ITI STENTIntratherapeutics, Inc. · 1998-07-21

Official Source

View FDA Recall →

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

↑