Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Bolton Medical Inc., FSN-2247858-02-22-2021-001C, RelayPlus and Relay 85

   Urgent Field Safety Notice RelayPlus and Relay 85.

   Waarschuwing | 25-02-2021

2. Endologix Inc, FSN-FS-0012, Ovation Abdominal Stent Graft System Platform

   This FSN is specific to the following Ovation iX Abdominal Stent Graft Systems, and impacts all lot/serial numbers: TV-AB2080-I, ...

   Waarschuwing | 06-05-2020

3. W.L. Gore & Associates, 3007284313.12102019.001-C, GORE EXCLUDER AAA Endoprosthesis & GORE IBE

   Gore investigated these events and identified two (2) types of failure modes: unbonded leading end catheter components (olives) ...

   Waarschuwing | 19-12-2019

4. Elekta Instrument AB, FCA-EIAB-0008, Leksell Vantage Arc System

   Elekta has found that the design of the Instrument Carrier is not optimal which may cause the locking mechanism at the interface ...

   Waarschuwing | 08-06-2020

5. Maquet Cardiovascular, LLC/Getinge, 2242352-05/21/2024-001-C, VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2

   lf there is fluid ingress into the handle of the operating tool, the device may not provide cautery or may continue to provide ...

   Waarschuwing | 20-06-2024

6. Applied Medical Resources Corporation, 2027111-01/26/24-001-R, CA500, Epix UNIVERSAL CLIP APPLIER 3/BX

   Applied Medical is conducting a Field Safety Corrective Action of specific lot numbers of its Epix® Universal Clip Applier due to ...

   Waarschuwing | 18-03-2024

7. SYMATESE, FSN-HEM/PAN-21-001-V2, PANGEN® and HEMOTESE®

   Several complaints have been registered by SYMATESE following a difficulty encountered when opening the external pouch of ...

   Waarschuwing | 27-06-2023

8. Atrium Medical Corporation 3011175548-02/25/2022-001-C - Advanta V12 Covered Stent System

   Atrium/Getinge is initiating a voluntary Medical Device Field Correction for the Advanta V12 Covered Stent System due to an ...

   Waarschuwing | 15-03-2022

9. W. L. Gore & Associates, Inc. Medical Products Division, 2017233.09.15.2022.001-R, GORE® CARDIOFORM ASD Occluder

   Gore has identified one batch of GORE® CARDIOFORM ASD Occluder devices that was incorrectly released following a documented ...

   Waarschuwing | 26-09-2022

10. Stryker Joint Replacement, FSN-RA2020-2527314, Mako Integrated Cutting System (MICS)

    Stryker has initiated a voluntary, serial number specific recall for the Mako Integrated Cutting System (MICS).

    Waarschuwing | 03-11-2020