Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Becton Dickinson Infusion Therapy AB FSN-MDS-22-4560 BD Connecta Stopcocks

   Becton Dickinson has identified internally that the specific product Lots (listed in Appendix 1) may present a hole or rupture in ...

   Waarschuwing | 08-11-2022

2. 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

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. 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

5. Keystone Heart FSCA-RR-2022-001 - TriGUARD 3 Cerebral Embolic Protection Device

   Keystone Heart has become aware of a manufacturing error relating to a 3rd party supplier, which has resulted in a planned ...

   Waarschuwing | 24-05-2022

6. Maquet_Getinge FSCA 598097 - Heater Unit HU 35

   Based on the internal complaints investigation and extensive material compatibility testing under aggrevated conditions ...

   Waarschuwing | 18-05-2022

7. Osatu, S.Coop FSCA RECALL 0322 R300-500 - REANIBEX 300-500

   REANIBEX 300 and REANIBEX 500 defibrillators may be displaying a battery charge value sufficient to perform defibrillation ...

   Waarschuwing | 04-05-2022

8. Abbott Medical Dragonfly OpStar April 11, 2022 - Dragonfly Opstar Imaging Catheter

   Bij producten van deze partijen kan de proximale marker loskomen van de katheter. Een losgeraakte marker kan bijkomende ...

   Waarschuwing | 20-04-2022

9. Abbott FA-Q122-CRM-1 - Merlin™ and Merlin™2 Patient Care System (PCS)

   Indien een gebruiker de knop “Hold to Test” indrukt en besluit te stoppen met testen door de knop los te laten voordat de eerste ...

   Waarschuwing | 28-03-2022

10. Oscor Inc., FSN-1035166-12/22/2021-01-R/22-002-CMDR, Destino Twist / Brand Name: Guidestar

    During use of the Affected Products, the colored hub cap and seal may disengage which could result in patient harm associated ...

    Waarschuwing | 20-01-2022