Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Boston Scientific Corporation, FSN-92630745-FA, LOTUS Edge Valve System

   Boston Scientific (BSC) voert een vrijwillige verwijdering van ongebruikte voorraad van het LOTUS™ Edge klepsysteem uit.

   Waarschuwing | 16-11-2020

2. William Cook Europe ApS, FSN-2020FA0005, Zenith Alpha® Abdominal Endovascular Graft

   Cook Medical has identified that specific lots of the Zenith Alpha® Abdominal Endovascular Graft (21MB main body) may contain ...

   Waarschuwing | 10-08-2020

3. The Spectranetics Corporation D055703 Bridge® Occlusion Balloon

   The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in ...

   Waarschuwing | 26-03-2020

4. Neovasc Inc. FCA 19-001-C - Neovasc Reducer

   Neovasc has discovered an error in the expiration date of the Reducer System Lot No. 190131-01. Since the Reducer Kit expiration ...

   Waarschuwing | 18-02-2020

5. Cordis Corporation Cordis20191113-OUS - PRECISE, S.M.A.R.T., S.M.A.R.T. Control

   Cordis became aware that the Instructions for Use (IFU) for the S.M.A.R.T. and PRECISE stents do not have correct language around ...

   Waarschuwing | 13-11-2019

6. Bard Access Systems Inc VT-RAP-18-10-002 BardPort, X-Port and Groshong

   Er is met behulp van feedback van de klant vastgesteld dat voor de producten met een combinatie van productcode/lotnummer die in ...

   Waarschuwing | 08-10-2019

7. Maquet Cardiopulmonary GmbH FSCA-2019-09-11 Adult Small Adult VKMOs and VHK

   During verification testing of Adult/Small Adult VKMOs and VHK a potential impairment of the sterile packaging barrier was ...

   Waarschuwing | 12-09-2019

8. Maquet Cardiopulmonary GmbH FSCA-2019-09-10 Adult Small Adult Venous Hardshell Cardiotomy Reservoir (VHK) and combination of reservoir with oxygenator (VKMO(D))

   During verification testing of Adult/Small Adult VKMOs and VHK a potential impairment of the sterile packaging pouches of the ...

   Waarschuwing | 11-09-2019

9. Occlutech GmbH FSCA-20190724 - Occlutech Delivery Set

   Occlutech Delivery Sets (ODS) bestaan uit meerdere componenten: inbrenghuls, lader, hemostaseventiel en dilatator. Occlutech ...

   Waarschuwing | 24-07-2019

10. Abbott Vascular FSCA MitraClip® XTR May 1, 2019 - MitraClip® XTR Clip Delivery System

    Abbott has confirmed reports of XTR Clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive ...

    Waarschuwing | 29-04-2019