The Recall Desk

Manufacturer

Jenavalve Technology Inc.

3 recalls in our database name Jenavalve Technology Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
3
Most recent
2026-10-21

Of the 3 recalls from Jenavalve Technology Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • SevereFDA (Devices)·Z-0136-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 143 JenaValve Trilogy Delivery Catheters due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0134-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 111 units of JenaValve Trilogy Delivery Catheters due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0135-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 108 units of the JenaValve Trilogy Delivery Catheter due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
    Category
    Medical Device
    Distribution
    Distributed nationwide