Jenavalve Technology Inc. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-LClass IIJul 31, 2026Delivery Catheter may have sleeve liner separation that res	Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart	Class IIDevices	Jul 31, 2026
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-MClass IIJul 31, 2026Delivery Catheter may have sleeve liner separation that res	Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart	Class IIDevices	Jul 31, 2026
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-SClass IIJul 31, 2026Delivery Catheter may have sleeve liner separation that res	Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart	Class IIDevices	Jul 31, 2026