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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 051 12 17 000
Date submitted: 12/14/2017
Manufacturer:Boston Scientific
Device Type:Malecot Nephrostomy Catheter System, Malecot Nephrostomy Catheter Set, Re-Entry™ Malecot Nephrostomy Catheter Set and Percutaneous Access Set
Description:Catheter, nephrostomy
Medical Device Identifier:Material Numbers: M0064101000, M0064101010, M001224110, M0064101040, M0064101050, M0064201150
All batch number are affected
Reason of Field Safety Corrective Action:Boston Scientific (BSC) is initiating a removal of certain Malecot Nephrostomy Catheters due to reports of some catheters breaking at the mid-shaft bond during use. The bond is located where the renal end of the Malecot catheter is bonded to the catheter shaft. BSC has received seventeen (17) complaints for this issue since December 1, 2013. There have been no injuries reported as a result of this issue.
Remedy Action:Boston Scientific is advising users to inspect stock and quarantine any remaining units of the affected product. Stock can be returned to Boston Scientific for credit.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:RC-2017-RN-01498-1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Boston Scientific.pdf