The Recall Desk

Manufacturer

IMPULSE DYNAMICS (USA) INC

1 recall in our database name IMPULSE DYNAMICS (USA) INC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2024-02-28

Of the 1 recalls from IMPULSE DYNAMICS (USA) INC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–1 of 1

  • HighFDA (Devices)·Z-1173-2024·2024-02-28

    OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy

    The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.

    Product
    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
    Category
    Medical Device
    Distribution
    Distributed nationwide