BEUDAMED
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    AGENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·October 28, 2025

    AGENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·January 22, 2026

    AGENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·January 22, 2026

    DRUG-ELUTING STENT (NIQ)

    FDA Adverse Event
    Product code NIQ·April 25, 2015

    NIQ STENT, CORONARY, DRUG-ELUTING

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·December 22, 2008

    NIQ STENT, CORONARY, DRUG-ELUTING

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·April 3, 2009

    LIBERTÉ?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·June 8, 2015

    GORE VIABAHN ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·August 1, 2020

    AGENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·October 28, 2025

    Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code NIQ·October 7, 2013

    Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.

    FDA Recall
    Terminated ·Cordis Corporation·Product code NIQ·January 12, 2005

    Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A,

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIQ·March 25, 2020

    Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx

    FDA Recall
    Terminated ·Cordis Corporation·Product code NIQ·November 18, 2004

    TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Part Numbers correspond to the lot numbers listed at the end of the code information below. US part# H7493897024250 H7493897032270 H7493897020300 H7493897020350 H7493897032300 H7493897020350 H7493897024300 H7493897020300 H7493897020300 H7493897032350 H7493897020250 H7493897020270 H7493897024300 H7493897032350 H7493897032270 H7493897020350 H7493897024300 H7493897024250 H7493897024250 H7493897020300 H7493897032350 H7493897032350 H7493897024350 H7493897024250 H7493897024250 H7493897016300 H7493897032350 H7493897024350 H7493897016350 H7493897032300 H7493897016350 H7493897016350 H7493897024350 H7493897016250 H7493897016250 H7493897024300 H7493897024350 H7493897016250 OUS part# H7493800132270 H7493800132270 H7493800132350 H7493800132270 H7493800124350

    FDA Recall
    Terminated ·Boston Scientific Scimed·Product code NIQ·July 1, 2004

    Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.

    FDA Recall
    Terminated ·Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland·Product code NIQ·August 6, 2009

    Coronary Drug-Eluting Stent

    FDA classification
    FDA Class 3 ·Coronary Drug-Eluting Stent

    SYNERGY¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 9, 2016

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 10, 2016

    SYNERGY¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 24, 2016

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 5, 2016