The Recall Desk

Manufacturer

LivaNova USA

5 recalls in our database name LivaNova USA as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2019-01-30

Of the 5 recalls from LivaNova USA we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) 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.

1–5 of 5

  • SevereFDA (Devices)·Z-1901-2018·2018-05-30

    LivaNova Recalls Sorin Stockert Heater-Cooler Systems Due to Suspected Microbial Contamination

    LivaNova USA is recalling 2,408 Sorin Stockert Heater-Cooler System 3T units because they are suspected of microbial contamination and may contain visible biofilm.

    Product
    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1919-2018·2018-05-30

    LivaNova Inspire 8 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

    LivaNova USA is recalling 70 units of Inspire 8 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.

    Product
    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adu
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-1918-2018·2018-05-30

    LivaNova Inspire 6 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

    LivaNova USA is recalling 42 units of Inspire 6 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.

    Product
    Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adul
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-0664-2018·2018-02-28

    LivaNova Recalls Sorin Group Smart Perfusion Packs Due to Incorrect Expiration Date

    LivaNova USA is recalling 16 units of Sorin Group Smart Perfusion Pack E-Packs because they are labeled with incorrect expiration dates.

    Product
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
    Category
    Medical Device
    Distribution
    1 state

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.

LivaNova

UK business

Country
United Kingdom
Founded
2015

Official website

Source: Wikidata (Q21592516), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.