Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Becton Dickinson MDS-20-1971 - BD PosiFlush™ XS 10mL Syringe

   BD has become aware through customer feedback that a percentage of BD PosiFlush™ XS 10mL Syringes (REF: 306572) have the ...

   Waarschuwing | 21-04-2020

2. Defibtech FA2020-01 - DDU-2000 Series Automated External Defibrillator (AED)

   This corrective action addresses a hardware issue with a particular electrical component used in the identified AEDs.  This ...

   Waarschuwing | 21-04-2020

3. Medtronic, Inc. FA908 HeartWare® Ventricular Assist System (HVAD)

   Van de bijna 22.000 HVAD-pompen die tot en met 5 maart 2020 zijn gedistribueerd, heeft Medtronic 92 klachten (0,42%) ontvangen ...

   Waarschuwing | 07-04-2020

4. 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

5. Teleflex_Vascular Solutions HRA00077 - Langston Dual Lumen Catheter

   Op de datum van deze brief heeft Vascular Solutions LLC, een dochteronderneming van Teleflex, acht meldingen ontvangen waarbij ...

   Waarschuwing | 25-03-2020

6. LeMaitre Vascular CAPA 2020-001 - LeMaitre Over the Wire Embolectomy Catheter, 5F Plus

   Uit de klachten in 2020 blijkt een toenemende trend van wegglijdende ligatuur/scheiding van de tip. Als de ligatuur wegglijdt, ...

   Waarschuwing | 24-03-2020

7. Intervascular SAS RC034 - HEMASHIELD GOLD - HEMASHIELD PLATINUM

   The issue was identified through five complaints received between July 2018 and September 2019 reporting intra-operative bleeding ...

   Waarschuwing | 23-03-2020

8. Synovis MCA FA-2020-008 - GEM Microvascular Anastomotic COUPLER

   Synovis Micro Companies Alliance (MCA), Inc., a subsidiary of Baxter International Inc., is issuing a voluntary product recall to ...

   Waarschuwing | 10-03-2020

9. Medtronic FA906 - Pipeline Flex Embolization Device

   Medtronic has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of ...

   Waarschuwing | 27-02-2020

10. 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