Medical device manufacturer, Cook Medical, issued a medical device safety alert concerning its Gunther Tulip Vena Cava Filter Set and Celect Platinum Vena Cava Filter Set. The affected devices are identified as the following:
According to the manufacturer, the Instructions for Use for the William Cook Europe ApS Gunther Tulip Vena Cava Filter Set and Celect Platinum Vena Cava Filter Set has been updated. The added information reflects well-known safety information associated with endovascular procedures requiring anesthesia and contrast media.
The target population for the Gunther Tulip and Celect Platinum Vena Cava Filter Sets remains unchanged; specifically, these devices are intended for patients at risk for pulmonary embolism (PE). However, the IFU updates includes contraindications for two specific patient groups (i.e., minors/pediatrics and pregnant women). While healthcare professionals may assess the potential benefit of IVC filter placement to outweigh the potential risk in these patients, this update reinforces the fact that safety and performance of the Gunther Tulip and Celect Platinum IVC filter implants have not been established in these patients.
The manufacturer is instructing affected users to take note of amendment/ reinforcement of IFU.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Sep 2021