The Food and Drug Administration (FDA) of the United States has issued a medical device safety alert
concerning Angiodynamics Soft Vu Omni Flush Angiographic Catheter, manufactured by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions).
The affected devices are identified as follows:-
According to the FDA, the manufacturer is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due to reports of separation of the tip of the catheter from the main body. Tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs.
Tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health consequences, including death.
The manufacturer sent a customer notification letter to affected customers informing them of the high possibility of tip separation during use and customers are advised to discontinue use of the affected lots of the recalled products.
According to the local supplier, the affected products are not distributed in Hong Kong.
For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm512644.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm512633.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2016