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Express 2 OTW

by Boston Scientific Scimed, Inc. PMA

Withdrawn United States

PMA P020009

Overview

The Express 2 OTW is a coronary stent system designed to improve coronary luminal diameter in patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries. It is indicated for lesions less than 18 mm in length with a reference vessel diameter of 3.0 to 5.0 mm, and for treatment of abrupt or threatened abrupt closure in failed interventional therapy cases.

This over-the-wire (OTW) stent system is supplied as a permanent implant and is indicated for use in native coronary arteries of 2.25 to 5.0 mm in diameter and less than 30 mm long. Long-term outcomes beyond six months for this permanent implant are currently unknown. The device is authorized under FDA PMA P020009.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Withdrawn since 11 Sep 2002. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP020009 Date11 Sep 2002Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Withdrawn

Recalls

3 recalls · FDA

    • Terminated Z-1121-04 FDA Unclassified (pre-2012) initiated 16 Jul 2004

    Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.

    • Terminated Z-1123-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003

    There is an Increased potential for broken struts of the stents.

    • Terminated Z-0711-03 FDA Unclassified (pre-2012) initiated 20 Mar 2003

    The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.

Specification

PMA

Trade Name
Express/Express 2 Mr & Otw Coronary Stent Systems
Generic Name
STENT, CORONARY
PMA Number
FDA Product Code
MAF
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APWD Approval withdrawn

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Questions

  • What is the Express 2 OTW stent system indicated for?

    The Express 2 OTW stent system is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries (length < 18 mm) with a reference vessel diameter of 3.0 to 5.0 mm, and for treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions of 2.25 to 5.0 mm diameter and < 30 mm long.

  • Is long-term outcome data available for the Express 2 OTW stent beyond six months?

    No, long-term outcome (beyond 6 months) for this permanent implant is unknown at present, as stated in the approval documentation for the Express and Express2 Monorail and Over-the-Wire Coronary Stent Systems.

  • Who manufactures the Express 2 OTW coronary stent system?

    The Express 2 OTW coronary stent system is manufactured by Boston Scientific Scimed, Inc., located in Maple Grove, Minnesota.