Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Occlutech GmbH, FSCA-2024-002, Figulla Flex II ASD Occluder

   Occlutech has identified that products affected by this corrective action have a size recommendation of ODS III (REF 98DS006) on ...

   Waarschuwing | 23-12-2024

2. St. Jude Medical, FA-Q123-SH-2 Trifecta, Trifecta Valve Trifecta Valve w. Glide Technology

   Abbott verstrekt hierbij informatie betreffende structurele hartklepverslechtering (Structural Valve Deterioration, SVD)1 in ...

   Waarschuwing | 01-03-2023

3. Abbott Vascular, Clip Delivery System September 07 2022, MitraClip and TriClip Delivery Systems

   Het hogere aantal meldingen betreft clips waarbij het niet mogelijk is de ‘definitieve armhoek te bepalen’ (EFAA,Establish Final ...

   Waarschuwing | 03-10-2022

4. Abbott, Clip Delivery System September 08, 2022, MitraClip- en TriClip- Delivery System(s)

   Het hogere aantal meldingen betreft clips waarbij het niet mogelijk is de ‘definitieve armhoek te bepalen’ (EFAA, Establish Final ...

   Waarschuwing | 27-09-2022

5. Bhavana, FSN-RA2020-2430533, Trevo Retriever

   Stryker Neurovascular division has initiated a Product Recall on lots of Trevo XP ProVue Retriever devices manufactured during ...

   Waarschuwing | 02-10-2020

6. B. Braun Melsungen AG, FSCA-VS-2023-01, Invasive blood pressure transducer set

   As users already know, prolonged contact with organic solvents (spray disinfectants) can promote the formation of stress cracks ...

   Waarschuwing | 22-01-2024

7. Philips Medical Systems Nederland BV, 2023-IGT-BST-020, Philips Azurion 7 M20 FlexArm system with Maquet M

   Philips is op de hoogte gebracht van twee mogelijke veiligheidsproblemen met het Azurion 7 M20 Flexarm-systeem ("Flexarm") met ...

   Waarschuwing | 22-01-2024

8. Maquet Cardiopulmonary GmbH, 874275, Custom Tubing Packs

   It was reported that there was gas leaking from the cardioplegia line.

   Waarschuwing | 31-10-2023

9. Datascope Corp. Getinge, 2249723-05.05.2023-008-C, Cardiosave Intra-Aortic Balloon Pumps

   There have been reports of IABP units losing the ability to charge batteries in one or both bay slots due to a failure in the ...

   Waarschuwing | 16-06-2023

10. Maquet Cardiopulmonary GmbH, 74922 . 745922, PLS Set; HLS Set Advanced5.0; HLS Set Advanced 7.0

    Maquet Cardiopulmonary GmbH (MCP) has received a communication from a regulatory body in which the conformity of the products ...

    Waarschuwing | 09-02-2023