Medical device manufacturer, Clinical Innovations, has issued a medical device recall concerning ebb Complete Tamponade System [Part number: CTS-1000; Lot number: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068].
The manufacturer identified a leak may occur from the distal end of the uterine balloon after receiving six reports of uterine balloon leakage during use. A uterine balloon with a leak may not provide the anticipated tamponade effect, requiring further intervention to control postpartum haemorrhage. Death could unlikely occur due to this failure mode.
The affected products are being recalled.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 January 2015