The Recall Desk

Manufacturer

Cardiogenesis Corporation

1 recall in our database name Cardiogenesis Corporation as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2013-09-18

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

1–1 of 1

  • SevereFDA (Devices)·Z-1993-2013·2013-09-18

    Cardiogenesis Transmyocardial Laser Recalled Due to Sparks and Burns

    Cardiogenesis Corporation is recalling 2,498 Transmyocardial Laser devices due to reports of sparks, burns, or smoke incidents.

    Product
    Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atheros
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Cardiogenesis

medical device company

Founded
1989

Source: Wikidata (Q5038703), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.