Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. DePuy Mitek, 2244073, Bioknotless Anchor

   This FSN is to alert users that applying bending force and/or bending force with impaction to the BIOKNOTLESS® Anchor Inserter ...

   Waarschuwing | 04-05-2023

2. MAQUET Cardiovascular LLC, 2242352‐02.17.2023‐002‐R, Hemopro 2

   Maquet Cardiovascular, LLC/Getinge was notified by their sterilization provider (Steris) that for a period of roughly five ...

   Waarschuwing | 21-04-2023

3. pfm medical mepro gmbh, FSN-2023-02, Kölner Drainage Redon Bottle

   For articles from the affected batches, the opening behaviour of the green pinch-off piece on the bottle may be impaired (see ...

   Waarschuwing | 11-04-2023

4. 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

5. Medtronic Inc., FSN-FA1319, ACCY B31030 EXTENSION TUNNELER DBS

   Medtronic heeft meldingen ontvangen van kits met tunneler voor de SenSight™-verlengkabel waarbij de tunneler dubbele dragers ...

   Waarschuwing | 30-03-2023

6. BIOTECK SPA, FSCA REF: 230307, BIO-GEN/GRANULES

   The falsified devices bear the name BIO-GEN® and the indication of Bioteck SpA as the manufacturer but have packaging ...

   Waarschuwing | 29-03-2023

7. Richard Wolf GmbH, FSN-FSCA700020652, FLEX. GRASP. FORCEPS or FLEX. BIOPSY FORCEPS

   We have received complaints from users stating that the forceps can no longer be opened during use. Our investigation has shown ...

   Waarschuwing | 23-03-2023

8. VitreQ B.V., PRE-20220006, CryoTreQ

   Vitreq B.V. has become aware of two incidents which described that a CryoTreq device suddenly and forcefully disassembled after ...

   Waarschuwing | 15-03-2023

9. Intuitive Surgical, Inc., ISIFA2022-14-C, da Vinci Xi and da Vinci X Surgical System

   Deze veiligheidsmededeling is bedoeld om u erop te wijzen dat een deel van de instrumentarmen (USM's) van het da Vinci X- en Xi ...

   Waarschuwing | 15-03-2023

10. Boston Scientific Corporation, FSN-92984351-FA, Habib EndoHPB Bipolar Radiofrequency Catheter

    Deze veiligheidskennisgeving levert belangrijke informatie met betrekking tot het gebruik van de Habib EndoHPB-katheter in ...

    Waarschuwing | 13-03-2023