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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 036 09 11 000
Date submitted: 9/14/2011
Manufacturer:BIOTRONIK
Device Type:Cardiac catheter guidewire, Cruiser Hydro
Description:Cardiac catheter guidewire, single-use
Medical Device Identifier:Ref. 351455, 351456, 351457, 351458, 351459. (Lots attached)
Reason of Field Safety Corrective Action:The flexible distal tip of some of the tested articles did not meet the specifications. This may increase the likelihood of tip fracture during the procedure.
Remedy Action:Discontinue any further use of the affected Cruiser Hydro lots. A BIOTRONIK sales representative will contact you to collect the affected products.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh (01) 2119999
Report Source:NCAR
Source Ref. Number:CH-2011-09-09-032
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BIOTRONIK- Field Safety Notice.pdf