Jenavalve recalls
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Jenavalve and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-10-21FDA-DeviceClass IIJenavalve Trilogy catheter recalled for deployment failure risk
Jenavalve Technology Inc. is recalling certain Trilogy Delivery Catheter devices (27MM, REF: TRILOGY-DC-L) because the sleeve liner may separate inside the catheter. This separation can make it difficult or impossible to properly deploy the heart valve device during surgery.
- 2026-10-21FDA-DeviceClass IIJenaValve Trilogy Delivery Catheter recalled for deployment risk
JenaValve Trilogy Delivery Catheter (Size 25MM, REF: TRILOGY-DC-M) may experience separation of the sleeve liner, which can prevent or delay deployment of the heart valve device during surgery. This affects 108 units distributed across the US and several European countries.
- 2026-10-21FDA-DeviceClass IIJenavalve Trilogy Delivery Catheter recalled for deployment failure risk
The Jenavalve Trilogy Delivery Catheter (Size 23MM, REF: TRILOGY-DC-S) may experience separation of the sleeve liner, which could make it difficult or impossible to deploy the heart valve device during the procedure. The FDA has classified this as a Class II recall.
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