Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Maquet Cardiopulmonary GmbH, 879551, CARDIOHELP-i

   The IFU of the CARDIOHELP system states incorrect factory settings. The device itself is working as intended and the error only ...

   Waarschuwing | 10-11-2023

2. Maquet Cardiopulmonary GmbH, 881841, Cardiohelp-i

   The root cause of the improper contact originates in an incorrect drawing of the production tool in question, resulting in an ...

   Waarschuwing | 06-11-2023

3. Maquet Cardiopulmonary GmbH, 812435, Rotaflow II drive flex.compact

   In October 2022 Maquet Cardiopulmonary received a complaint on issues connected to the yellow locking mechanism unlocking on ...

   Waarschuwing | 11-07-2023

4. 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

5. Boston Scientific Corporation, 96993356-FA, IntellaNav StablePoint Ablation Catheter

   Boston Scientific gaat specifieke partijen van de INTELLANAV STABLEPOINT-ablatiekatheter terugroepen, doordat een foutief ...

   Waarschuwing | 11-04-2023

6. 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

7. GELITA MEDICAL GmbH, FSN-CR-22-006, GELITA-SPON STANDARD, GELITA-SPON RAPID3, GELITA ENT X-BLOD, GELITA ENT X-DENSE, GELITA ENT X-PAND, GELITA ENT X-PASTE, GELITA-SPON POWDER

   In re-testing ordered by the manufacturer, the endotoxin concentration of the product in some samples has been measured above the ...

   Waarschuwing | 16-08-2022

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. LeMaitre Vascular, CAPA 2022-001-NL, AlboGraft Polyester Vascular Graft

   LeMaitre trekt bepaalde AlboGraft-apparaten terug en ruilt ze om vanwege een wijziging in de wettelijke status.

   Waarschuwing | 11-03-2022

10. Medtronic FA1197 - Abre™ Venous Self-expanding Stent System

    Medtronic heeft in overleg met een onafhankelijk artsenpanel geconcludeerd dat enige aanpassing van het gebruik kan helpen om het ...

    Waarschuwing | 14-12-2021