BEUDAMED
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    Rapid Oxygen R15

    FDA UDI
    RAPID OXYGEN INC·10860466001808·The R-15 oxygen generator provides on-demand ox...

    VAPOTHERM PRECISION FLOW(R) - HELIOX

    FDA Adverse Event
    Malfunction ·VAPOTHERM INC·Product code BTT·December 24, 2013

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·December 28, 2023

    UNKNOWN CORPAK NASOGASTRIC TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·March 16, 2019

    INOGEN G5 PORTABLE OXYGEN CONCENTRATOR

    FDA Adverse Event
    Death ·INOGEN, INC.·Product code CAW·January 21, 2025

    DIALOG®

    FDA Adverse Event
    Death ·B. BRAUN AVITUM AG·Product code KDI·July 21, 2022

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·August 6, 2024

    ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR

    FDA Adverse Event
    Death ·AVANOS MEDICAL·Product code MEB·October 19, 2018

    PRESSURIZED ELASTOMERIC INFUSION DEVICE

    FDA Adverse Event
    Injury ·UNK·Product code MEB·December 8, 2021

    HEMODIALYSIS BLOODLINES

    FDA Adverse Event
    Injury ·B. BRAUN MEDICAL INC·Product code FJK·March 7, 2022

    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