The Recall Desk

Manufacturer

Acutus Medical Inc

4 recalls in our database name Acutus Medical Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
4
Most recent
2020-04-29

Of the 4 recalls from Acutus Medical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (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.

1–4 of 4

  • SevereFDA (Devices)·Z-1769-2020·2020-04-29

    Acutus Medical AcQGuide Introducer Recalled for Foreign Material Particulates

    Acutus Medical Inc is recalling 268 units of AcQGuide Mini Fixed-Curve Introducers because manufacturing defects may have left foreign material on the devices.

    Product
    Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1770-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Flextra Steerable Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 30 units of Rhythm Xience Flextra Steerable Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1768-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Guider Catheter Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 108 units of Rhythm Xience Guider Catheter Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1771-2020·2020-04-29

    Acutus Medical Recalls AcQGuide Flex Steerable Introducer Due to Foreign Material

    Acutus Medical Inc is recalling 5 units of the AcQGuide Flex Steerable Introducer because manufacturing defects may have left foreign material particulates on the device.

    Product
    Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
    Category
    Medical Device
    Distribution
    3 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.

Acutus Medical

medical technology company

Country
United States

Official website

Source: Wikidata (Q124352446), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.