The Recall Desk

Manufacturer

SynCardia Systems Inc.

3 recalls in our database name SynCardia Systems Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
2
Severe
1
Most recent
2016-12-14

Of the 3 recalls from SynCardia Systems Inc. we have scored against our rubric, 2 (67%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) 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

  • CriticalFDA (Devices)·Z-0659-2017·2016-12-14

    SynCardia Freedom Driver System Recalled for Potential Silent Failure

    SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.

    Product
    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-2731-2015·2015-09-23

    SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure

    SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.

    Product
    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of immine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0620-2013·2013-01-09

    SynCardia Recalls Companion External Batteries Due to Thermal Event Risk

    SynCardia Systems is recalling Companion External Batteries used with the Companion 2 Driver System because they may be at risk of thermal events or physical damage.

    Product
    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to trans
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.

SynCardia Systems

artificial heart manufacturer

Founded
2001

Official website

Source: Wikidata (Q17143479), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.