Structural heart disease implant developer Occlutech said it’s recalling some of its Occlutech left atrial appendix occluders over risks of dislocation of the device both during and post-procedure.
The Occlutech LAA occluder is designed for the minimally invasive closure of the LAA to reduce the risk of stroke in patients with atrial fibrillation. The device consists of a flexible nitinol wire mesh and loop anchoring and sealing technology, the Swiss company said.
The company said that during both the LAA trial and commercial use, 4 dislocations were reported. After reviewing the dislocations, the company said it will need “a more extensive operator training program and clearer guidance” to prevent future dislocations.
Occlutech did not state whether or not adverse events had been reported associated with the dislodgments in its recall notice.
The recall affects all lots, serial numbers and sizes of devices with product codes 30LAA18, 30LAA21, 30LAA24, 30LAA27, 30LAA30 and 30LAA33.
The company said it has suspended shipping and selling of the LAA Occluder and its stock has been taken out of circulation. Occlutech advised customers with the devices to respond and perform follow-ups to verify the devices were not dislodged.
Occlutech won CE Mark approval in the European Union for its LAA occluder device in June.