Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. HeartWare Inc., FA944, HVAD Pump Implant Kit

   Medtronic is providing this letter as a follow-up to our...communications ... regarding the HeartWare™ Ventricular Assist Device ...

   Waarschuwing | 27-10-2022

2. COMEPA INDUSTRIES, FSN-FSCA-NC017, BBCOM ELECTRODE PEDRIATRIC

   Comepa is immediately recalling from the market the BBCOM Electrodes and PRECOM Electrodes devices. Reason for withdrawal: ...

   Waarschuwing | 24-10-2022

3. Boston Scientific Corporation, FSN-92946782-FA, EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD

   Boston Scientific roept wereldwijd ongeveer 150 EMBLEM™ Subcutane Implanteerbare Cardioverter-Defibrillatoren (S-ICD's) model ...

   Waarschuwing | 24-10-2022

4. Edwards Lifesciences LLC, FSN-FCA-173, Fogarty Arterial Embolectomy Catheters Pouch-Pack, Fogarty FORTIS Arterial Embolectomy Catheters Pouch-Pack & Fogarty Biliary Balloon Probes Pouch-Pack

   Edwards Lifesciences heeft meldingen ontvangen dat het niet mogelijk is de ballon op te blazen of de integriteit van de ballon te ...

   Waarschuwing | 24-10-2022

5. 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

6. 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

7. 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

8. Philips Medical Systems, FSCA 2022-CC-HPM-051, MR Patient Care Portal 5000

   During manufacturing inspection of the MR Patient Care Portal 5000, it was discovered that two (2) Portal 5000 units would ...

   Waarschuwing | 22-09-2022

9. MicroPort, CRM-SAL-2022-001, XFINE

   Risk of Minute Ventilation artefact oversensing in patients with a subset of abnormal high polarization XFine passive pacing ...

   Waarschuwing | 20-09-2022

10. Medtronic, FA1277, Prevail Paclitaxel-coated PTCA Balloon Catheter

    Het doel van deze brief is u te informeren dat Medtronic specifieke loten van de Prevail Paclitaxel PTCA-ballonkatheters met ...

    Waarschuwing | 19-09-2022